PREAS - PHARMA REGULATORY AFFAIRS SERVICES DIVISION
DMF/Dossier Preparation, Compilation and CTD/eCTD Submission, Regulatory Strategies, Life-cycle Management, Product Labelling
Pharma Regulatory Affairs
We are a global pharmaceutical Regulatory Affairs consulting organization. We offer comprehensive regulatory affairs solutions for registering and marketing drug products, product life-cycle management for pharmaceutical products, biosimilars, and medical devices.
Regulatory affairs require due diligence to review regulatory documents related to APIs as well as finished drug products, CMC data generation for regulatory filings, and other related matters.
Our teams of experienced professionals take up and deliver all sorts of pharmaceutical regulatory assignments for the US, European, and emerging markets including DMF preparation, dossier compilation, and submission, medical writing, IND module 2 clinical and non-clinical summaries, and overview as well as developing comprehensive regulatory strategy.
We also provide technical consultancy with respect to formulation strategies, 505(b)2 route, IVIVC, Biowaivers, QbD, Stability, Clinical trials, Technology transfer, GxP compliance, Computer system validation, instruments & software with the help of globally acclaimed industry experts.
Research, Instruments, Products, and Services Promotion to Scientific CommunitiesDetails
Technical, Research & Regulatory Solutions for Pharma, Clinical & Other Industry R & D ScientistsDetails
Dossier Preparation, CTD/eCTD Submission, Lifecycle Management, Regulatory StrategiesDetails