CFRA Associates 

Regulatory Affairs Consultation

Navigating the regulatory landscape is crucial for the success of your products. Our regulatory consulting services encompass a wide range of areas, including product registrations, regulatory submissions, labeling compliance, pharmacovigilance, and post-marketing surveillance. Our experts stay up to date with global regulations, providing you with the latest guidance and ensuring your products meet all necessary compliance of the US FDA, EU, HC, CDSCO, and all other geographical regulatory requirements for pharma, drugs, biologicals, medical devices, and food industries. 

•  We develop regulatory strategy roadmaps from the concepts to product launch which include support for the IDE, 510 (k), DeNovo, HDE, PMA,  Post-market surveillance (PMCFs, PSURs & PMS), Change control Submissions, and Annual Reports submissions for Medical Devices. 

•  We develop regulatory strategy roadmaps from the concepts to products launch which include support for the 505 (b)(2), IDA/IMPD ANDA, EUA, NDA/BLA, MAA, Post-market surveillance, Post Approval Changes (CB0, CB30, PAS), & Annual reports for drugs and biologicals. 

•  We support pre-sub meetings with agencies, response to 483's, Concern Degrees, warning letters, and Documentation and remediations for pharma, drugs, biologicals, and medical devices.

• Technical File Preparation EU MDR/IVDR, CE Marking, UKCA, Dossier (CTD/eCTD) Preparation, Review, and Submissions. 

•  Artwork and Labelling Work, UDI Implementation, IFU, remediation, labeling services, Creating, Updating, and managing Company Core Data Sheet (CCDS).