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