Product Life Cycle Management
RAAJ GPRAC regulatory consultants bring a deep understanding of effective lifecycle management and have the knowledge to offer a complete regulatory solution for your product when marketed across the globe.
We have many years of experience in product life-cycle management and are responsible for the maintenance of large, medium-sized and small pharmaceutical and biotech companies.
As a team of specialists in current medicinal regulations in EU, USA and many other countries, we can assist you in all of your product medicinal product life-cycle management needs.
- Developing a regulatory strategy for extending your product line or lifecycle
- Advising on regulatory requirements for variations and acting as project manager for the process
- Compiling, writing, preparing, and publishing the submission
- We compile, organize, write, and edit a range of high-quality regulatory and safety documents that include clinical development plans, study protocols, investigator brochures, informed consent documents, pre-clinical and clinical study reports, common technical documents, safety narratives, and aggregated reports (PSURs, NDA PRs) which are regularly followed in clinical trials services in India
- Serving as the primary point of contact with national and local health authorities
- Product variation / amendment application - Defining the type of variation (Type I or Type II for EU, PAS, CBE 30 or APR for USA), reviewing technical data, preparation of application and submission to health authority.
- Efficiency for Variations, Renewals and Notifications
- Complete portfolio maintenance for EU, USA and RoW
- Preparation and submission of grouped variations for Europe
- Management of labelling
- Promotional material review