Services

Regulatory Strategy

Combination Product (CP) regulatory submission strategies – development of original strategies (for reducing regulatory risk) or reviews of existing strategies for maximizing regulatory success.

Doc Submission and Support

Dossier and submission preparation of CP-specific sections for IND/IMPDs, FDA and EMA Briefing Documents and support for health authority meetings, NDAs/BLAs/MAAs, and supplements and variations that incorporate content for device descriptions, principles of operation, human factors testing, risk analyses, and design and development activities, including post approval delivery device design changes.  

Due Diligence

Reviews of start-up biopharma companies, expecting to rely on delivery devices, to determine if there are viable pathways to approval and what those requirements are likely to be.