Regulatory
Knowledgeable in the FDA, HPFB, and EMEA regulatory requirements for clinical testing and marketing approval of drugs and devices
- Regulatory submission oversight, management, preparation, and maintenance (U.S., Canada, and E.U.)
- INDs, IMPDs and CTAs, or individual dossier components
- NDAs, ANDAs, NDS’ and MAAs in CTD format or individual dossier components
- CMC-specific: IND, IMPD, NDA, ANDA, NDS, MAA, DMF/EDMF, European Pharmacopeia Certificate of Suitability
- Preparation of regulatory submission technical sections and summaries
- Orphan drug designation applications
- U.S. Agent services for U.S.-based regulatory submissions
- Regulatory authority liaison and meetings
- Regulatory strategy development, implementation, and management
- Regulatory compliance gap analysis of product development plans and submissions
- Regulatory Support and Submission Services