Piscataway, NJ, USA -08854
Global Regulatory Affairs Overview
Regulatory affairs is a critical function in the healthcare industry, as it ensures that products are safe and effective for patients and consumers.
Regulatory Affairs
The primary goal of our regulatory affairs service is to ensure that products are safe, effective, and meet the regulatory requirements of the country or region where they are being marketed.
Regulatory Activities
The process of ensuring that products, devices, and/or drugs comply with the regulations and guidelines set by regulatory bodies, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe or other Regulatory bodies across the globe.
Pre-Approved
- Dossier submission to the Agency
- Response to Agency queries
- Clinical and non-clinical activities
- Create Master dossier / documents
- Labeling
- Dossier compilation as per Agency’s required format
Approval/Rejection
- Marketing Authorization Applications (MAA) for Europe
- ANDA, NDAs for US
- Medical Devices
- Food supplements
- Over the counter drugs
- Biological Licensing Applications.
Post-Marketing
- European Variations
- NDA/ANDA supplements compilation and submission
- Renewal Applications
- Change Control Management
- PSUR’s Submissions
- Labeling Updates
Labelling and Artwork
- Labeling updates and amendments and Country specific label conversions
- Author, update and amend CCDS
- Readability testing for PILs, package inserts
- Artwork operations and Preparation/review of promotional material
