Regulatory strategy includes product development, approval, and post-market compliance according to guidance from the FDA (US), MHRA (UK), EMA (EU) and/or other agencies.
Clients come to Kinexum with varying levels of urgency and needs, from pressing issues, such as lifting a clinical hold or salvaging results of an unsuccessful clinical trial, to informational questions on topics like possible pathways to approval, time and cost to complete clinical development, commercial potential, or obtaining a meaningful safety or efficacy signal.
Kinexum helps you consider broader options than you may have imagined. For instance:
- Even if a new formulation or indication for an existing drug qualifies for a 505(b)(2) NDA, when might it make sense to seek a 505(b)(1) NDA?
- When might it make sense to seek a de novo rather than a 510(k) medical device clearance?
- Would it make sense to pair a 510(k) cleared device with a therapeutic to develop a drug-device label, to benefit from drug pricing and exclusivity?
- What should be considered when conducting clinical trials outside of the US? Should they be conducted under an FDA IND?
- What case can be made to a regulatory authority to shorten the transition from Phase 2b to Phase 3? Is a product eligible for accelerated or conditional approval, with a commitment to perform a negotiated post-approval trial?
- In what order should special designations (e.g. Orphan Drug, Fast Track, Breakthrough, Regenerative Medicine Advanced Therapy, or Rare Pediatric Disease) be sought?
The services we offer include:
- Regulatory strategy and pathway analysis
- Requests, questions, and informational packages for FDA meetings (e.g. pre-IND; INTERACT; pre-submission; end of Phase 2; pre-NDA; and Type A, B, C and D meetings)
- Submissions for regulatory compliance (e.g. IND, EOP2, 505(b)(1) and (2), NDA, BLA, IDE, 510(k), de novo, PMA and post-marketing submissions)
- Designations (e.g. Orphan Drug, Fast Track, and Breakthrough)
- Chemistry, manufacturing, and controls (CMC)
- Medical device design history
- Regulatory maintenance (periodic reports and amendments) and US agent services
