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

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