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 life cycle management solutions:
- Annual Reports and Periodic Adverse Drug Experience Reports (PADERs)
- Changes Being Effective: CBE-0 and CBE-30 Supplements
- Prior Approval Supplements (PAS)
- 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
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.