Dr. N C Prakash Reddy
Consultant- Regulatory, Vaccines, Technical and Clinical Trials
Bengaluru
Summary
Accomplished professional with 24 years of experience in Regulatory Affairs, Technical, CMC, Manufacturing, Quality and Clinical Trials. Successfully registered and maintained 150+ products across multiple regions. Deep expertise in Vaccines, Drugs, Drugs & Cosmetics Act 1945, FSSR 2011, and Legal Metrology Act 2009. Proven track record of contributing to industry bodies like the Indian Pharmacopoeia Commission, focusing on regulatory strategies for vaccines and biologicals. Skilled in mentoring teams towards achieving organizational goals.
Overview
25
25
years of professional experience
18
18
years of post-secondary education
1
1
Certification
Work History
Consultant for Lallemand and Alivira
Globlaunch
09.2023 - Current
- Mentoring Regulatory Affairs (RA) teams and facilitating application filings with CDSCO, GEAC, and DBT.
- Providing expert opinions on CMC, Regulatory Affairs, and product portfolio strategies.
- Collaborating with the Department of Environment (GEAC) and DBT for vaccine and GMO product approvals.
- Offering technical guidance from document preparation to final approval.
- Establishing Institutional Biosafety Committees, conducting periodic meetings, and securing approvals.
- Advising new product development teams, identifying clinical sites, managing Key Opinion Leaders (KOLs), and overseeing protocol development and monitoring.
- Strategizing product filings with CDSCO to ensure timely approvals.
Head - Regulatory Affairs and Pharmacovigilance (SA)
Boehringer Ingelheim India Pvt Ltd
09.2015 - 08.2023
- Achieved complete registration of products with the Drugs Controller General of India Office as per RA plans.
- Successfully registered 25 products with FSSAI, including diagnostic kits and vaccination equipment.
- Ensured compliance in packaging development, adhering to regulatory standards.
- Served as a Member of the Indian Pharmacopoeia Commission, contributing to a Special Task Force for developing CDSCO Guidance Documents.
- Cultivated strong relationships with external stakeholders: Department of Health (DCGI), Genetic Engineering Appraisal Committee, Indian Pharmacopoeia, DBT, CDTL, IVRI.
- Led the regulatory department, maintaining a flawless compliance record across a diverse product portfolio.
- Managed Periodic Safety Update Reporting (PSUR) for all registered products.
- Focused on people mentoring and development within the department.
Associate Director Regulatory & Pharmacovigilance
Sanofi Synthelabo India Pvt Ltd
09.2015 - 02.2017
- Oversaw Regulatory and Pharmacovigilance activities.
- Managed key accounts, provided training, and coordinated with local regulatory agencies.
- Planned new products and launch strategies.
- Handled techno-marketing and trained field staff.
- Managed adverse event reporting and other safety issues to regulators.
- Supported Sales, Marketing, and Supply Chain in new product launches.
- Successfully accomplished registration of planned products in Bangladesh and Sri Lanka.
- Engaged in people mentoring and development.
Head Technical
Pfizer (Zoetis India Pvt Ltd)
07.2013 - 09.2015
- Supported Regulatory and Marketing teams in achieving company objectives and goals.
- Completed 2 Global Clinical trials in India.
- Trained Sales and Marketing staff, coordinating with Animal Husbandry, Cooperative Unions, and other key accounts.
- Planned new product development aligned with portfolio and business needs.
- Developed a database of experts, CROs, and government institutions for KOLs and Clinical Trials.
- Focused on people mentoring and development.
Head Technical & Clinical Trials
Indian Immunologicals Ltd
01.2011 - 07.2013
- Managed CMC documentation for all exported products, leading to the registration of over 38 products in ME, South Asia, South Africa, Russia, Mongolia, and Africa.
- Conducted Clinical Trials for Vaccines, Nutraceuticals, and NSAIDs.
- Trained field force, promoted products, and delivered technical presentations to veterinarians.
- Involved in disease investigation and outbreak reporting.
- Conducted Clinical trials and bridging studies including BA/BE, Safety trials, and Post-Marketing Surveillance (PMS).
- Focused on people mentoring and development.
Viral Vaccines - Head
Indian Immunologicals Ltd
01.2009 - 01.2011
- Mastered the production of Companion Animal Vaccines (Distemper, Parvovirus, Parainfluenza, Canine Adino Virus, Canine Corona Virus, Leptospira) and Bacterial Vaccines (Black Quarter, Hemorrhagic Septicemia, Enterotoxaemia, Anthrax, Brucellosis).
- Expertise in the production of Foot and Mouth Disease Vaccine.
- Implemented GMP and HSE practices across all workplaces, including greenfield projects.
- Successfully completed GMP audits.
- Developed SOPs for all operations.
- Managed a team of over 50 employees.
Head Quality
Indian Immunologicals Ltd
01.2005 - 01.2009
- Introduced Vaccines Testing protocols as per Indian Veterinary Pharmacopoeia monographs (2001).
- Established Payloads for FMD vaccine and submitted correlation (payload vs. potency data) to the Government of India.
- Completed numerous GMP audits and trained personnel in Quality Control activities.
- Introduced Total Quality Management (TQM) concepts within the organization.
- Established Master, Working, and Seed banks for all bacterial and viral vaccines.
- Recruited and trained over 30 executives, establishing career progression paths.
- As Disease Security Regulation Officer, established Disease Security in all premises handling pathogenic viruses and animal containment zones.
Executive Quality
Indian Immunologicals Ltd
01.2001 - 01.2005
- Conducted In-Vivo and In-Vitro testing of Vaccines.
- Responsible for SOP writing.
- Ensured GMP Compliance, supporting CMC and clinical documentation for the Regulatory department.
- Involved in running Clinical trials and Preclinical trials.
Education
Executive MBA -
IIM Lucknow
Ph.D. - Biotechnology
JNTU
MVSC - Pharmacology
BVC
BVSC - undefined
BVC
No Degree - Generative AI
Outskill
Hydeabad 04.2001 -
Skills
Regulatory Affairs
Product Registration
Dossier Preparation
Regulatory Compliance
Liaison with MoH
Liaison with DCGI
Liaison with GEAC
Liaison with DBT
Liaison with FSSAI
Liaison with IPC
Liaison with Legal Metrology
Vaccines & Biologicals
Viral Vaccines
Bacterial Vaccines
Disease Security Regulation
Biosafety Committees
Quality & GMP
GMP Compliance
Quality Control
SOP Development
Audits
TQM
Master Bank establishment
Working Bank establishment
Seed Bank establishment
Clinical Trials
Pharmacovigilance
Protocol Development
Clinical Site Identification
KOL Management
Global Clinical Trials
Adverse Event Reporting
PSUR
Leadership
Mentorship
Department Head
Team Mentoring
Training & Development
Strategic Planning
Legal & Documentation
Drugs & Cosmetics Act
FSSR
Legal Metrology Act
DGDA guidelines
Technical Writing
Report Writing
Certification
Generative AI Mastermind, Outskill, Certificate of Completion
Accomplishments
- Registered over 40 products in India and more than 150 products in BNS (Bangladesh, Nepal, Sri Lanka) countries.
- Secured approvals from DCGI, Ministry of Agriculture, and Ministry of Environment, Forest and Climate Change for over 50 products.
- Contributed significantly to various industry bodies and the preparation of IPC monographs.
- Developed and updated test methods for Indian Pharmacopoeia (2002) for bacterial and viral vaccines (F1 Schedule to I.P), including TQM activities.
- Completed Dossiers for Registration in Asia, ME, Africa, and Russia as a Member of the Business Group-Exports.
- Developed and tested lab scale and commercial scale products, including Eprinomectin pour-on and Nimesulide Injection (BA/BE and Clinical Trials).
- FMD challenge strain adaptation, correlation, and payload studies conducted and submitted to the Government of India.
- Member of Committee to study the need for Avian Influenza (AI) vaccines in India to reduce human exposure.
Timeline
Consultant for Lallemand and Alivira
Globlaunch
09.2023 - Current
Head - Regulatory Affairs and Pharmacovigilance (SA)
Boehringer Ingelheim India Pvt Ltd
09.2015 - 08.2023
Associate Director Regulatory & Pharmacovigilance
Sanofi Synthelabo India Pvt Ltd
09.2015 - 02.2017
Head Technical
Pfizer (Zoetis India Pvt Ltd)
07.2013 - 09.2015
Head Technical & Clinical Trials
Indian Immunologicals Ltd
01.2011 - 07.2013
Viral Vaccines - Head
Indian Immunologicals Ltd
01.2009 - 01.2011
Head Quality
Indian Immunologicals Ltd
01.2005 - 01.2009
No Degree - Generative AI
Outskill
04.2001 -
Executive Quality
Indian Immunologicals Ltd
01.2001 - 01.2005
Ph.D. - Biotechnology
JNTU
MVSC - Pharmacology
BVC
BVSC - undefined
BVC
Executive MBA -
IIM Lucknow