Regulatory Compliance Associates® Inc.’s expertise in pharmaceuticals extends to existing products on the market. We can help with regulatory strategy and dossier content management throughout your product’s entire lifecycle, including the following:
- Annual Reports and Periodic Adverse Drug Experience Reports (PADERs)
- Changes Being Effective: CBE-0 and CBE-30 Supplements
- Prior Approval Supplements (PAS)
- Amendments
- Drug Master File (DMF) or Legacy Application Conversion to Electronic Common Technical Document (eCTD) Format
- eCTD Publishing Capabilities to Meet Agency Publishing Requirements
- Type 1 and Type 11 Variations (EU)
- Gateway / Portal Access for Submissions to FDA, Health Canada, and EMEA