RCA’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)
- Abbreviated New Drug Application (ANDA)
- Amendments
- Changes to Supplier Sourced Material
- Changes to Meet New Agency Publishing Requirements
- Type I and Type II Variations (EU)
