Regulatory Strategy and Compliance

Regulatory strategy includes product development, approval, and post-market compliance with guidance from regulatory agencies, including FDA (US), MHRA (UK), and EMA (EU).

Clients come to Kinexum with varying levels of urgency. Some have from pressing issues, such lifting a clinical hold or salvaging results of an unsuccessful trial. Others have informational questions on topics like accelerated approval pathways, the time and cost to complete clinical development, the commercial potential of a product, or obtaining a meaningful safety or efficacy signal.

Our services include:

Regulatory strategy and pathway analysis (e.g. gap analysis)
Requests and informational packages for (e.g. INTERACT; pre-submission; Type A/B/C/D)

Submissions for regulatory compliance (e.g. IND, EOP2, 505(b)(1/2), NDA, BLA, IDE, 510(k), de novo, PMA and post-marketing)

Label negotiations

Kinexum helps you weigh all your options. For instance:

Even if my drug qualifies for a 505(b)(2) NDA, when should I seek a 505(b)(1) NDA?

When should I seek a seek a de novo rather than a 510(k) medical device clearance?

How might my 510(k)-cleared device be paired with a therapeutic, to access drug pricing and exclusivity?

How can I conduct clinical trials outside the US? Should they be conducted under an FDA IND?

How can I shorten the transition between Phase 2b and Phase 3? Is my product eligible for accelerated or conditional approval?
In what order should I seek special designations (e.g. Orphan Drug, Fast Track, Breakthrough, Regenerative Medicine Advanced Therapy, Rare Pediatric Disease)?