Swetha Ramoju

• Write and edit clinical documents like study reports, protocols, safety reports.
• Review listings, graphs other data as per Statistical analysis plan and clinical protocols.
• Spearheaded efforts to optimize existing templates for consistency across all documents produced by the department.

• Involved in the formulation development of various solid and liquid oral formulations.
• Involved in preparation and review of high-quality documentation, product development reports for Regulatory submission.
• Preparation of amendments in response to the complete response, Information request and easily correctable deficiencies letters issued by regulatory authorities.
• Thorough understanding of Drug Master Files and identification of, to be e-published documents against the regulatory requirements throughout product life-cycle.
• Investigation of market complaints of various products (EU/US markets).
• Evaluation and Proposal for Shelf-life extensions feasibility for various formulations.
• Initiation and Proposal for specifications for finished products.
• Ensure the content, quality of analytical reports as per pharmacopoeia specification, Standard Testing Procedures, Batch Manufacturing Records, Stability protocols.
• Identify and propose solutions to resolve issues and questions arising during the formulation development process, including resolution or escalation as appropriate.
• Involved in the review of Target product profiles and preparation of strategic drug development plans.
• Proven experience in cross functional work management.
• Understanding on working with information management systems, project management systems and/or reporting tools.

• GPKPD Team - Worked on 'Assessment of impact of age, gender and food on PK of a highly variable drug'
• Handling clinical PK/PD data and creating a database
• Phoenix win- nonlin execution; Nonlinear mixed effect modeling basics
• Established support to Global pharmacokinetics-Pharmacodynamics scientists

Summary of project: The factors age, gender and food were found to have small quantifiable impact on PK parameters. However the magnitude of impact was insignificant from PK point of view

• Understanding on Modified release initiatives of various Novartis Pharma products: Various reasons for the development of MR formulations were studied and justified
• Worked on the development of clinical PK/PD study database: Clinical database was developed and a user friendly interface was developed.