REGULATORY AFFAIRS
Your Partner for Regulatory Affairs and Compliance Support
Our Regulatory consulting and operations team are experts with in-depth knowledge of regulatory requirements of different agencies globally. All aspects of marketing authorization applications are handled by a multi-disciplinary team of trained regulatory affairs professionals. We help with all your regulatory needs for global projects with our expertise and decades of experience.
Services We Offer
- All authority interactions
- Preparation, review & submission of dossiers
- Gap analysis & strategic planning for registration
- Conversion to CTD and eCTD
- New MAAs, IMPDs, DMFs & CEPs
- Brexit-related regulatory services, International Recognition Procedure (IRP) etc.
- ANDAs, NDAs, INDs, 505(b)(2) applications
- On-site training on regulatory topics
- Pharmaceuticals/ APIs/ Medical Devices/ In-vitro Diagnostics/ Nutraceuticals/ Cosmetics/ Herbal products/ Biotechnology & biosimilar products
- Life cycle management including post approval submissions – variations/supplements and renewals/annual reports
- Data generation
- Publishing services including eCTD publishing, NeeS submission, CSR reports etc
- Generation of expert reports in line with the current regulations
- Artwork management including, artwork design, labelling compliance, prescription drug labelling, OTC labelling, structured product labelling, regulated labelling etc
- Scientific Advice
- Additional Services - QP, Batch release site, Batch Testing Site, PIL user testing, Local MAH etc.