Summary
Overview
Work History
Education
Skills
Certification
Publications
Regulatory Audits
Timeline
Hi, I’m

RAHUL V. MAYEE

Pharmacokinetic Expert
Visakhapatnam,AP
RAHUL V. MAYEE

Summary

A well experienced professional with over 21+ years of experience in Bioequivalence, Pharmacokinetics, Quality Assurance and PM Abilities in undertaking Clinical research studies to meet deadlines. Exposure in planning and organizing day-to-day research activities and resolving procedural problem as appropriate to the timely accomplishment of research objectives. Exercises judgment within generally defined practices in applying scientific methods & techniques in an innovative way for obtaining research solutions. An effective communicator with excellent relationship management skills & strong analytical, problem solving & organizational abilities.

Overview

22
years of professional experience
4
years of post-secondary education
2
Certifications
2
Languages

Work History

Actimus

AGM
09.2022 - Current

Job overview

  • Designing the PK, BA/BE studies based on the regulatory requirements. Designing the PK and Stat analysis approaches.
  • Responding to Regulatory, Sponsor queries for Protocol Design, Statistical Approaches, Way forwards based on the obtained PK data etc
  • Overall in-charge of Protocol Writing and Pharmacokinetic Department
  • Review of protocol, and to Provide regulatory inputs during preparation of protocols
  • Preparation and review of SOPs
  • To supervise and train Department team

VerGo Clinicals

Head PM and MW
02.2022 - 09.2022

Job overview

  • Overall in-charge of department and accountable for all its functions
  • Monitoring and ensuring that all activities in the department comply with SOP’s
  • Responsible for carrying out literature search for project feasibility and coordinating with PI, Bioanalytical department and biostatistician for the same
  • Review of protocol, Clinical study reports and eCTD reports
  • Provide regulatory input during preparation of protocols
  • Review of informed consent document as per regulatory requirements and New Drugs and Clinical Trial Rules 2019
  • Corresponding with the translator for Translation and back translation of documents and review for accuracy of translation and back translation
  • Preparation and review of SOPs
  • Co-ordination with investigators and sponsors for finalization of clinical study report
  • ECTD and CDISC
  • Co-ordination with respective department, Investigators and Sponsor in responding to report related and regulatory queries
  • Review of Study Schedule and communicate same to Sponsor and Ethics Committee
  • Updating sponsor of the study progress
  • Maintenance of study slots and project trackers and follow up for study progress from initiation to archival
  • Review of submission of BE-NOC and T-license application to DCGI
  • Communication with Sponsor, regulatory agency and external agency as applicable
  • To supervise and train medical writing and Project Management team
  • Further any work assigned by Site Head

BioRadius Therapeutic Research Pvt. Ltd

Head MW
10.2020 - 02.2022

Job overview

  • Mentors and leads less experienced medical writers on complex projects, as necessary
  • Acts as lead for assigned writing projects
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
  • Develops or supports a variety of documents that include, but not limited to:
  • Clinical study protocols and clinical protocol amendments;
  • Clinical study reports
  • Clinical Study Updates
  • CRFs
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate
  • Reviews statistical analysis data and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
  • Serves as peer reviewer on internal review team providing review comments on draft and final documents
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
  • Performs on-line clinical literature searches, as applicable
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
  • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership
  • Completes required administrated tasks within the specified timeframes

BioRadius Therapeutic Research Pvt. Ltd

Head QA
03.2019 - 10.2020

Job overview

  • Manage global Quality Assurance GCP Auditing personnel for the conduct of internal audits of the following to assess GCP compliance with ERT SOPs, ICH Good Clinical Practices, and EN ISO 9001l, ISO 13485, Sponsor requirements, and regulatory authorities:
  • Internal departments/processes
  • Project specific processes/requirements
  • Computer systems
  • Vendors
  • Perform internal audits and gap analyses to ensure compliance with ERT SOPs, ICH Good Clinical Practices, and ISO and applicable regulatory requirements for all technical operations
  • Develop auditing plans and reports for assigned audits
  • Maintain the status of identified audit findings in the Quality Assurance Database/CAPA Tracking System
  • Perform tracking/trending analysis of audit findings and assist operations in the implementation of corrective action plans, as appropriate
  • Manage corrective action and preventive action responses received for internal and defined for external audit observations
  • Perform continued maintenance to ensure timelines are current
  • Support Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness
  • Author Quality Assurance/Regulatory Affairs standard operating procedures as required
  • Assist with the development and implementation of department specific Standard Operating Procedures
  • Assist with the hosting and management of client audits
  • Analyze observations identified and generate effective responses
  • Perform routine quality reviews of key documents defined by OSCR related to:
  • Change Control
  • System Requirements
  • Testing/Validation Records
  • Installation Qualification
  • System Maintenance Records
  • Migration Records, Conduct ongoing internal meetings to monitor internal quality programs and issues
  • Provide SOP Development & Implementation, Annual Quality Assurance and Regulatory Affairs Training Courses to ERT staff, as necessary
  • Provide consulting services to contracted external sources as required
  • Assist in the development or execution of system testing as required
  • Detailed Job description:
  • Periodic review of SOPs in compliance with GCP and GLP requirements
  • Assistance in the implementation of regulatory requirements
  • Organization and conduct of different, highly professional trainings
  • Within the Quality Management System (QMS)
  • SOP trainings
  • General GCP compliance training
  • General GLP compliance training
  • Performing audits:
  • Pre-Regulatory Inspection GCP and GLP Audit
  • Audits of Quality Systems and Procedures
  • On line and Retrospective Audit
  • System/facility Audit
  • Independent Investigational site audits
  • Trial Master file or Study File audits
  • Database set up and lock audits
  • Study report audits
  • Due Diligence audits
  • Vendor & Service Provider Audits/Assessments
  • Risk assessment and contingency plan development
  • Compliance gap analysis and resolution
  • Corrective and Preventive Action Plans (CAPA)
  • Developing an efficient QMSs
  • Standard Operating Procedures development and implementation
  • Reviewer for regulatory query/inspection responses
  • Liaison with other department in-charge for implementation, maintenance and up gradation of QA system
  • Updating higher management related to quality issues timely basis.

BioSRL Pvt. Ltd

QA Manager
10.2017 - 03.2019

Job overview

  • Manage global Quality Assurance GCP Auditing personnel for the conduct of internal audits of the following to assess GCP compliance with ERT SOPs, ICH Good Clinical Practices, and EN ISO 9001l, ISO 13485, Sponsor requirements, and regulatory authorities:
  • Internal departments/processes
  • Project specific processes/requirements
  • Computer systems
  • Vendors
  • Perform internal audits and gap analyses to ensure compliance with ERT SOPs, ICH Good Clinical Practices, and ISO and applicable regulatory requirements for all technical operations
  • Develop auditing plans and reports for assigned audits
  • Maintain the status of identified audit findings in the Quality Assurance Database/CAPA Tracking System
  • Perform tracking/trending analysis of audit findings and assist operations in the implementation of corrective action plans, as appropriate
  • Manage corrective action and preventive action responses received for internal and defined for external audit observations
  • Perform continued maintenance to ensure timelines are current
  • Support Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness
  • Author Quality Assurance/Regulatory Affairs standard operating procedures as required
  • Assist with the development and implementation of department specific Standard Operating Procedures
  • Assist with the hosting and management of client audits
  • Analyze observations identified and generate effective responses
  • Perform routine quality reviews of key documents defined by OSCR related to:
  • Change Control
  • System Requirements
  • Testing/Validation Records
  • Installation Qualification
  • System Maintenance Records
  • Migration Records, Conduct ongoing internal meetings to monitor internal quality programs and issues
  • Provide SOP Development & Implementation, Annual Quality Assurance and Regulatory Affairs Training Courses to ERT staff, as necessary
  • Provide consulting services to contracted external sources as required
  • Assist in the development or execution of system testing as required
  • Detailed Job description:
  • Periodic review of SOPs in compliance with GCP and GLP requirements
  • Assistance in the implementation of regulatory requirements
  • Organization and conduct of different, highly professional trainings
  • Within the Quality Management System (QMS)
  • SOP trainings
  • General GCP compliance training
  • General GLP compliance training
  • Performing audits:
  • Pre-Regulatory Inspection GCP and GLP Audit
  • Audits of Quality Systems and Procedures
  • On line and Retrospective Audit
  • System/facility Audit
  • Independent Investigational site audits
  • Trial Master file or Study File audits
  • Database set up and lock audits
  • Study report audits
  • Due Diligence audits
  • Vendor & Service Provider Audits/Assessments
  • Risk assessment and contingency plan development
  • Compliance gap analysis and resolution
  • Corrective and Preventive Action Plans (CAPA)
  • Developing an efficient QMSs
  • Standard Operating Procedures development and implementation
  • Reviewer for regulatory query/inspection responses
  • Liaison with other department in-charge for implementation, maintenance and up gradation of QA system
  • Updating higher management related to quality issues timely basis.

BioSRL Pvt. Ltd

Clinical Research Manager
07.2016 - 10.2017

Job overview

  • SOP preparation and reviews for the project management department
  • Drafting and Reviewing Clinical Study Protocol
  • All Bioequivalence and bioavailability studies and Phase 1B, II and III clinical trial protocol development, getting the inputs from the expertise both in house and sponsors’, getting the protocol QA audit done and resolving the audit issues, if any, were the major responsibilities
  • Submission of Investigator’s Package to Ethics committee
  • Submission of the protocol and the study related essential documents (CRF / ICF), planning the IRB, incorporate the IRB recommendations, communicating the IRB decisions to the stake holders were the major responsibilities
  • Planning the Project
  • Scheduling:
  • To assign tasks to team members
  • To define how the team will work together
  • To define the communication plan
  • To set up necessary tracking system
  • To announce the project
  • Performing:
  • Inputs to protocol and other essential document preparation
  • To compare performance with plans with respect to:
  • Outcomes produced
  • Scheduled achievement
  • Resource expenditure
  • Deviations
  • Fixing problems that arise like changing task schedule or resources to get back on track
  • Communication with stakeholder
  • Closing:
  • Get approval/confirmation of the final results
  • Close all project accounts and finish up outstanding paperwork
  • Help people move on to their next assignment
  • Hold a post-project evaluation with the team.

Quintiles

Sr. Clinical Process Specialist
03.2016 - 07.2016

Job overview

  • Site Management
  • Support CL to develop Clinical Operations Plan (COP) using DTE-specific template, and study-specific documents, including: Monitoring Plan, SDV Plan and Study Reference, Manual/Guidelines/Instruction, annotated Site visit report and letter templates, scripts for remote monitoring visits and telephone contacts as applicable; Coordination with PDT for development of Various tools, templates, plans and training material; Ensure the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM
  • Request site monitor resources for site selection visits
  • Verifies training compliance and system access for the site management team involved during the study start-up; Review Project Ownership Accountability (POwA) within functional areas and annotate for changes or clarifications as needed per exception process; Support CL to develop Data Delivery/ Monitoring strategy including monitoring triggers/thresholds
  • Help develop Subject Level Data Review Plan and Data Segmentation Plan; Manage internal and external system access for Quintiles and study site teams; Verifies that all Helplines/toll free numbers have been requested and activated as per scope by each operational lead as appropriate (e.g
  • Helpdesk lead (EDC), PCC lead (PCC involvement) or QCC); Support CL to Develop and provide (e) CRF Completion Guidelines

Om Sai Clinical Research Pvt Ltd

Head QA
08.2013 - 02.2016

Job overview

  • Responsible for the Clinical Quality Assurance functions of the organization reporting to the MD
  • Ensuring planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies conducted at OSCR
  • Lead a team focusing on continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, along with OSCR policies and procedures for the conduct of clinical trials
  • This involves working closely with Clinical and analytical Operations, Information Technology, stat and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities, DUTIES AND RESPONSIBILITIES:
  • Manage global Quality Assurance GCP Auditing personnel for the conduct of internal audits of the following to assess GCP compliance with ERT SOPs, ICH Good Clinical Practices, and EN ISO 9001l, ISO 13485, Sponsor requirements, and regulatory authorities:
  • Internal departments/processes
  • Project specific processes/requirements
  • Computer systems
  • Vendors
  • Perform internal audits and gap analyses to ensure compliance with ERT SOPs, ICH Good Clinical Practices, and ISO and applicable regulatory requirements for all technical operations
  • Develop auditing plans and reports for assigned audits
  • Maintain the status of identified audit findings in the Quality Assurance Database/CAPA Tracking System
  • Perform tracking/trending analysis of audit findings and assist operations in the implementation of corrective action plans, as appropriate
  • Manage corrective action and preventive action responses received for internal and defined for external audit observations
  • Perform continued maintenance to ensure timelines are current
  • Support Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness
  • Author Quality Assurance/Regulatory Affairs standard operating procedures as required
  • Assist with the development and implementation of department specific Standard Operating Procedures
  • Assist with the hosting and management of client audits
  • Analyze observations identified and generate effective responses
  • Perform routine quality reviews of key documents defined by OSCR related to:
  • Change Control
  • System Requirements
  • Testing/Validation Records
  • Installation Qualification
  • System Maintenance Records
  • Migration Records, Conduct ongoing internal meetings to monitor internal quality programs and issues
  • Provide SOP Development & Implementation, Annual Quality Assurance and Regulatory Affairs Training Courses to ERT staff, as necessary
  • Provide consulting services to contracted external sources as required
  • Assist in the development or execution of system testing as required
  • Detailed Job description:
  • Periodic review of SOPs in compliance with GCP and GLP requirements
  • Assistance in the implementation of regulatory requirements
  • Organization and conduct of different, highly professional trainings
  • Within the Quality Management System (QMS)
  • SOP trainings
  • General GCP compliance training
  • General GLP compliance training
  • Performing audits:
  • Pre-Regulatory Inspection GCP and GLP Audit
  • Audits of Quality Systems and Procedures
  • On line and Retrospective Audit
  • System/facility Audit
  • Independent Investigational site audits
  • Trial Master file or Study File audits
  • Database set up and lock audits
  • Study report audits
  • Due Diligence audits
  • Vendor & Service Provider Audits/Assessments
  • Risk assessment and contingency plan development
  • Compliance gap analysis and resolution
  • Corrective and Preventive Action Plans (CAPA)
  • Developing an efficient QMSs
  • Standard Operating Procedures development and implementation
  • Reviewer for regulatory query/inspection responses
  • Liaison with other department in-charge for implementation, maintenance and up gradation of QA system
  • Updating higher management related to quality issues timely basis.

Rajarshi Shahu College of Pharmacy

Principal
07.2012 - 08.2013

Job overview

  • Principal and HOD (Pharmacology) In RSCP as Principal for UG and PG students along with the regular activities of running the academic setup I was also responsible for the research planning and the regularization of research-based publications of the PG students
  • Guidance to research was the major task at RSCP

Dr. VPPC

Principal and HOD
10.2009 - 06.2012

Job overview

  • During my days with Dr. VPPC College, I was mainly responsible as Principal for planning and executing the various academic programs, examinations and monitor the quality of education delivered to the students
  • Educating the students with personality development was my responsibility
  • I arranged various training programs and onsite training as well for students for the better understanding of what they learn theoretically in class rooms.

VedDoc Clinical Research Services Pvt. Ltd

Project Manager
11.2006 - 10.2009

Job overview

  • During my experience with VedDoc, I got involved in clinical trials belonging to two major therapeutic areas, Seasonal Fungal Infection, mental depression and diabetes
  • The study on the patients with fungal infection was Phase II study (dose determination) for the sponsors from overseas and depression and diabetes studies were for Indian MOH submission
  • The two studies on diabetic patients were Phase 1B and Phase III
  • All the three studies were multi centric and conducted across the Nation
  • I had been involved in the protocol development, study documentation development, investigator selection, feasibility assessment, and budget negotiation with the investigators, ethics committee submission, planning the clinical trial material procurement (study specific), planning the monitors visit at the site, continuous coordination with the sponsors, dealing with the regulatory affairs department, maintaining the study files etc
  • The team of two project coordinators and two Phase III CRAs were reporting to me for these trials.

Synchron Research Services Pvt. Ltd

Senior Project Coordinator
06.2004 - 10.2006

Job overview

  • SOP preparation and reviews for the project management department
  • Drafting and Reviewing Clinical Study Protocol
  • All Bioequivalence and bioavailability studies and Phase 1B, II and III clinical trial protocol development, getting the inputs from the expertise both in house and sponsors’, getting the protocol QA audit done and resolving the audit issues, if any, were the major responsibilities
  • Submission of Investigator’s Package to Ethics committee
  • Submission of the protocol and the study related essential documents (CRF / ICF), planning the IRB, incorporate the IRB recommendations, communicating the IRB decisions to the stake holders were the major responsibilities
  • Planning the Project
  • Scheduling:
  • To assign tasks to team members
  • To define how the team will work together
  • To define the communication plan
  • To set up necessary tracking system
  • To announce the project
  • Performing:
  • To compare performance with plans with respect to:
  • Outcomes produced
  • Scheduled achievement
  • Resource expenditure
  • Deviations
  • Fixing problems that arise like changing task schedule or resources to get back on track
  • Communication with stakeholder
  • Closing:
  • Get approval/confirmation of the final results
  • Close all project accounts and finish up outstanding paperwork
  • Help people move on to their next assignment
  • Hold a post-project evaluation with the team.

Accutest Research Labs

Project Coordinator
06.2002 - 06.2004

Job overview

  • In Accutest as a Sr. Project Coordinator, I had been responsible for the overall project management for the BA BE studies
  • Overlooking the projects and completing the different project tasks such as drafting the study protocol, ethics submission, CRF, ICF and other essential study document designing, announcing the project, maintaining the essential study files, communication with the stake holders, updating the stakeholders about the study proceedings and mile stones, monitoring the in house studies, making the draft and the final reports, were the major responsibilities.

OHM Labs

Junior Research Scientist
02.2002 - 06.2002

Job overview

  • Process Validation & Technical Support)
  • Provided the assistance to the Scientist, PDTS department, Ohm Labs and completed the report on the Process Validation and its Statistical Significance as a component of Evaluation in the course of Masters of Pharmacy.

Education

Chatrapati Shahuji Maharaj University
Kanpur

Doctor of Science from Pharmacology
04.2019 - 04.2023

Bhagwant University
Ajmer, Rajasthan

Ph.D from Pharmaceutical Sciences
06.2012

National Institute of Management
Mumbai

Ph.D from Clinical Research Management
04.2008

BITS
Pilani, Rajasthan

M. Pharma from Pharmacology & Pharmaceutical Chemistry
06.2002

Y.B. Chavan College of Pharmacy
Aurangabad

B. Pharma from Pharmacy
06.2000

Skills

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Certification

Training on Safety Data Management by Helix Research Center Pvt. Ltd., Hyderabad in 2005

Publications

  • Mayee R, Rawat S; ‘Pharmacokinetic Studies of Topical Formulations – A Review’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2010; 2(3): 98-100.
  • V. A. Arsul, R. Mayee, S. A. Bhale; “Development Of Ultraviolet Spectrophotometric Method For Determination Of Diclofenac Sodium In Stratum Corneum By Tape Stripping Method”, International Journal Of Current Research And Review, Sept 2010; Vol: 2 Issue 9: 23-28.
  • S. S. Rawat, R. V. Mayee, V. A. Arsul; “Validation of Ultraviolet Spectrophotometric Method for Determination of Diclofenac sodium in human stratum corneum by Tape stripping method using different dermal products”, International Journal Of Current Research And Review, December 2010; Vol: 2 Issue 12: 25-31.
  • Mayee R, Rawat S; ‘Dermatopharmacokinetic Approach to Evaluate and Compare the Pharmacokinetic Profile of Marketed Preparations of Diclofenac Sodium’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2011;3(1): 01-04.
  • Mayee R, Rawat S, Atre K, Mane P; ‘Evaluation Of Effect Of Pressure And Temperature On The Bioavailability Of Marketed Formulation Of Diclofenac Gel’, Int. Jou. of Medical and Pharmaceutical Sciences, March 2011;1(2): 1-8.
  • Mayee R, Rawat S, Atre K, Mane P; ‘Comparison between Marketed Formulations of Diclofenac Gel, Emugel and Spray for the Evaluation of Effect of Pressure and Temperature on Their Bioavailability’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2011;3(1): 15-20.
  • Mayee R, Rawat S; ‘Evaluation Of Effect Of Pressure And Temperature On The Bioavailability Of Marketed Formulation Of Diclofenac EmuGel’, International Journal Of Current Research And Review, May 2011; Vol: 3 Issue 5: 23-30.
  • Mayee R, Rawat S, Thosar A; ‘Evaluation Of Effect Of Pressure And Temperature On The Bioavailability Of Marketed Formulation Of Diclofenac Sodium’, Indo Global Journal Of Pharmaceutical Sciences, 2011; Vol:1 Issue 2: 134-141.
  • Mayee R, Rawat S, Thosar A, Atre K, Mane P, ‘Development and Validation of HPLC Method for Determination of Diclofenac Sodium by Tape Stripping Method’, Asian J Pharm Biol Res Apr-Jun 2011;1(3):260-265.
  • Mayee R, Rawat S, Thosar A, ‘In Vitro and In Vivo Investigation of Topical Formulations of Diclofenac Sodium’, International Journal of Universal Pharmacy and Life Sciences September-October 2011; 1(2):45-55.
  • Rahul M, Swati R, Ambrish T; Invitro Penetration Study of Diclofenac Sodium Using the Human Cadaver Skin, International Journal of Institutional Pharmacy and Life Sciences September-October 2011; 1(2):57-62.
  • Mayee R, Rawat S, Thosar A, Atre K, Mane P; ‘Adverse Event Reporting For A Dermatopharmacokinetic Study of Diclofenac Sodium Topical Formulations’, International Journal of Pharmaceutical Research 2011; 2(9): 185-187.
  • Mayee R, Thosar A, Kondapure A; ‘Evaluation of Hepatoprotective activity of the leaves of Nyctanthes arbor-tristis linn’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2010; 2(3): 109-111.
  • Prafulla Mane, Kavita Atre, Rahul Mayee; “Comparison Between The Pain Relieving Action Of Serratiopeptidase, NSAIDS And Combination of Both In The Root Canal Treatment Patients”, International Journal Of Current Research And Review, January 2011; Vol: 3 Issue 1: 11-17.
  • Rahul Mayee, Ambrish Thosar, Arun Kondapure; “Evaluation of Antiasthmatic Activity Of Calotropis Gigantea Roots”, Asian Journal of Pharmaceutical and Clinical Research, April 2011; Vol: 4 Issue 2: 33-35.
  • Prafulla Mane, Rahul Mayee, Kavita Atre; “Medicinal Properties of Allium Sativum (Garlic): A Review”, International Journal Of Pharmaceutical Research and Development, April 2011; Vol: 3 Issue 2: 145-150.
  • Mayee R, Thosar A; ‘Evaluation of Lantana camara Linn. (Verbenaceae) for Antiurolithiatic and Antioxidant Activities in Rats’, Int. Jou. Of Pharmaceutical and Clinical Research’, 2011; 3(1): 10-14.
  • Mayee R, Thosar A; ‘Evaluation of antibacterial activity of Moringa oleifera against some bacterial strains’, International Journal of Current Research and Review, April 2011; Vol: 3 Issue 4: 69-75.
  • Kavita Atre, Rahul Mayee, Sanjay Toshniwal; ‘Phenotyping an Overview’, International Journal of Current Research And Review, May 2011; Vol: 3 Issue 5: 56-63.
  • Mane P, Bhosale D, Thosar A, Mayee R, Atre K; ‘Pharmacovigilance Study of Disulfiram Using Patients With History Of Alcoholism’, Int. Jou. of Medical and Pharmaceutical Sciences, April 2011;1(3): 16-27.
  • Vilas A. Arsul, Supriya R. Wagh, Dr. Rahul V. Mayee; ‘Hepatoprotective Activity Of Livergen, A Polyherbal Formulation Against Carbon Tetrachloride Induced Hepatotoxicity In Rats’, Int. Jou. Of Pharmacy and P’Cal Sci’, 2011; 3(3): 228-231.
  • Prafulla Mane, Ambrish Thosar, Kavita Atre, Rahul Mayee; ‘The Need of Pharmacovigilance of Disulfiram - A Review’, International Journal Of Current Research And Review, June 2011; Vol 3(6): 92-97.
  • Pardeep Kaur, Farough Ahmed, Poorvi Sharma, Prafulla Mane, Kavita Atre, Rahul Mayee; ‘Lichen Planus: A Review’, Int. Jou. of Universal Pharmacy and Life Sciences, July-August 2011;1(1): 155-162.
  • Priyanka Wankhade, Prafulla Mane, Kavita Atre, Rahul Mayee; ‘To Study The Status Of Anaemia In Young Female Population Of Aurangabad Region’, Int. Jou. of Medical and Pharmaceutical Sciences, June 2011;1(4): 1-7.
  • Poorvi Sharma, Pardeep Kaur, Farough Ahmed, Prafulla Mane, Kavita Atre, Rahul Mayee; ‘Population Based Clinical Observational Study of Autoimmune Disorder Lichen Planus’, Int. Jou. of Institutional Pharmacy and Life Sciences, Sept-Oct 2011;1(2): 19-23.
  • Sandeep S Lahoti, S G Shep, Rahul V Mayee, S S Toshniwal; ‘Mucoadhesive Drug Delivery System: A Review’, Indo Global Journal Of Pharmaceutical Sciences, 2011; Vol:3 Issue 2: 243-251.
  • Santosh Shep, Sham Dodiya, Sandeep Lahoti, Rahul Mayee; ‘Swelling System: A Novel Approach Towards Gastroretentive Drug Delivery System’, Indo Global Journal Of Pharmaceutical Sciences, 2011; Vol:1 Issue 3: 234-242.
  • Charuvind K. Awale, Rahul Mayee; ‘Acetylator Phenotype in drug metabolism Relevant to Pharmacogenomics and Pharmacogenetics Sciences: - an Overview’, Int. Jou. of Pharmacy Research and Technology, 2011;1(2): 08-11.
  • Charuvind Awale, Kavita Atre, Rahul Mayee; ‘Phenotyping Study of Nat Enzyme Using Isoniazid as Substrate in Maharashtra Population’, Int. Jou. of Pharmacy Research and Technology, 2011;1(2): 22-26.
  • Shinde PV and Mayee RV, “Development and Evaluation of Press Coated Tablet of Aceclofenac”, International Journal of Pharmaceutical Innovations, Volume 2, Issue 1, Feb 2012, 6-15.
  • Shinde PV and Mayee RV, “Development and evaluation of press coated tablet by using rupturable material (EC) combined with erodible material (klucel EXF) of Aceclofenac”, International Journal of Pharmacy, 2(2), 2012, 380-385.
  • Shinde PV and Mayee RV, “A review: Current reported technologies used in pulsatile drug delivery system”, International Journal of Pharmacy Review and Research 2012, Vol 2, Issue 1, 23-30.
  • Shinde PV and Mayee RV, “Development and evaluation of floating pulsatile release tablet of Aceclofenac”, International Journal of Pharmacy & Technology, Vol. 4, Issue 1, April-2012, 3869-3877.
  • Shinde PV and Mayee RV, “Evaluation of pulsatile release of Aceclofenac tablets of the swelling, and rupturable layers of hydrophobic polymer Eudragit RSPO and RLPO combination”, International Journal of Advances in Pharmaceutical Research, Vol. 4 , Issue 1, Jan-2013, 1338 – 1342.
  • Shinde PV and Mayee RV, “Development of pulsatile release of Aceclofenac tablets with swelling and rupturable layers of ethyl cellulose”, Asian Journal of Biomedical & Pharmaceutical Sciences (AJBPS), Volume 2, Issue 15, 2012, 20-24.
  • Shinde PV and Mayee RV, “Evaluation of floating press-coated pulsatile release of Aceclofenac tablets by using various proportion of polymers such Hydroxypropyl methylcellulose (HPMC K 15 M and HPMC K 100 M)”, International Journal of Pharmaceutical Research and Development, Vol 4(11), January 2013, 73-82.
  • Ambarish Thosar and Dr. Rahul Mayee, “Effect Food On Pharmacpkinetics Of Drug”, Journal of GMP and Industrial Pharmacy, Vol. 7(1), February 2013, 53-57.
  • Vijay Pawar and Rahul Mayee, “Development and Validation of Hplc Method For Determination of Dapson And Monoacetyl Dapson From Humal Plasma”, Journal of GMP and Industrial Pharmacy, Vol. 7(1), February 2013, 7-12.
  • Vijay Pawar and Rahul Mayee, “Phenotyping Study of Drug Metabolizing Enzyme NAT Using Maharashtra Population Using The Probe Drug Dapson”, International Journal of Universal Pharmacy and Life Sciences 3(2): March-April 2013, 23-32.
  • Shivdas Dhas and Rahul Mayee, “Phenotyping Status of The Drug Metabolizing Enzyme CYP3A4 Using Atorvastatin As Substrate In Maharashtra Population”, IJUPLS, 3(2): March-April 2013, Page number: 11-22.
  • Shivdas Dhas and Rahul Mayee, “The Need of CYP3A Enzyme Family Phenotyping: A Review”, Journal of GMP & Industrial Pharmacy, 7(1): February 2013, Page number: 46-52.
  • Deepak Patil and Rahul Mayee, “Food Effect On Bioavailability of Drugs: A Review”, IJIPLS, 3(1): March-April 2013, Page number: 1-19.
  • Deepak Patil and Rahul Mayee, “Effect of Food On Pharmacokinetics of Clindamycin”, Journal of GMP & Industrial Pharmacy, 7(1): February 2013, Page number: 26-38.
  • Thakkar A and Mayee R, “Evaluation of Topical Bioavailability of Methyl Salicylate Using Dermatopharmacokinetic Method”, IJUPLS, 3(2): March-April 2013, Page number: 1-10.
  • Thakkar A and Mayee R, “In Vitro and In Vivo Investigation of Topical Formulations of Methyl Salicylate”, Journal of GMP & Industrial Pharmacy, 7(1): February 2013, Page number: 40-45.
  • Rahul Mayee, Ana Nikalje; “MORE Chemistry: An Eco-Friendly Technology”, National Conference on Hydro- chemical, Biochemical and Environmental Pollution, 2002.

Regulatory Audits

  • DCGI, India
  • MoH, Philippines
  • ISP, Chile
  • EMA, UK
  • USFDA, USA
  • MoH, United Emirates
  • MoH, Turkey


Timeline

AGM

Actimus
09.2022 - Current

Head PM and MW

VerGo Clinicals
02.2022 - 09.2022

Head MW

BioRadius Therapeutic Research Pvt. Ltd
10.2020 - 02.2022

Chatrapati Shahuji Maharaj University

Doctor of Science from Pharmacology
04.2019 - 04.2023

Head QA

BioRadius Therapeutic Research Pvt. Ltd
03.2019 - 10.2020

QA Manager

BioSRL Pvt. Ltd
10.2017 - 03.2019

Clinical Research Manager

BioSRL Pvt. Ltd
07.2016 - 10.2017

Sr. Clinical Process Specialist

Quintiles
03.2016 - 07.2016

Head QA

Om Sai Clinical Research Pvt Ltd
08.2013 - 02.2016

Principal

Rajarshi Shahu College of Pharmacy
07.2012 - 08.2013

Principal and HOD

Dr. VPPC
10.2009 - 06.2012

Training and Certification for membership by Indian Society for Clinical Research in 2008

08-2008

Project Manager

VedDoc Clinical Research Services Pvt. Ltd
11.2006 - 10.2009

Training on Safety Data Management by Helix Research Center Pvt. Ltd., Hyderabad in 2005

12-2005

Senior Project Coordinator

Synchron Research Services Pvt. Ltd
06.2004 - 10.2006

Project Coordinator

Accutest Research Labs
06.2002 - 06.2004

Junior Research Scientist

OHM Labs
02.2002 - 06.2002

Bhagwant University

Ph.D from Pharmaceutical Sciences
04.2012

National Institute of Management

Ph.D from Clinical Research Management
04.2008

BITS

M. Pharma from Pharmacology & Pharmaceutical Chemistry
04.2002

Y.B. Chavan College of Pharmacy

B. Pharma from Pharmacy
04.2000

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RAHUL V. MAYEEPharmacokinetic Expert