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