Regulatory Strategy and Compliance

Regulatory strategy fits within the client’s overall corporate strategy, including business model, corporate development and financing strategy, technology and/or FDA Guidance for lead product candidates and vision/mission.

Clients sometimes come to us with a laser-focused need, such as lifting a clinical hold, or any ways to salvage clinical trial results.  At other times, they want to know which target indication to prioritize, based on factors such as whether it is an orphan or broad indication; which indications have a clear pathway to approval; what options may be available in which FDA Center or Division; balancing factors such as time and cost to complete clinical development, the commercial potential, the competitive landscape, the likelihood of demonstrating a meaningful safety and efficacy signal, and multiple other factors.

Often, we help clients consider broader options than they first imagined:

• 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?
• If possible, would it make sense to pair a 510(k) cleared device with a therapeutic to develop a drug-device label, to support drug pricing and exclusivity?
• What are the considerations for conducting first clinical trials ex-US, and whether to conduct under an FDA IND?
• What case can be made to a regulatory authority to compress the transition from Phase 2b to Phase 3, or to seek Accelerated or conditional approval, with a commitment to perform a negotiated post-approval trial?
• What should be the sequence for seeking special designations (such as orphan drug, Fast Track, Breakthrough, Regenerative Medicine Advanced Therapy, Rare Pediatric Disease)

Kinexum experts can guide you through considering and deciding regulatory strategy, seeking FDA Guidance in the form of requesting, preparing for and participating in FDA meetings, and preparing submissions from clinical trial authorizations through marketing applications and post-marketing obligations. Services we offer include: 

• Regulatory Strategy and Pathway Analysis
• Regulatory Compliance 
• Gap Analysis 
• Preparation for FDA Meetings (e.g. pre-IND, INTERACT, pre-sub, End of Phase 2, Pre-NDA, and various Type A, B, C and D meetings. (including Meeting Requests with questions and Informational Packages) 
• Submissions for Regulatory Compliance (including required modules and appendices, for e.g., IND, EOP2, 505(b)(1) and (2) NDA, BLA, IDE, 510(k), de novo, PMA and post-marketing submissions), including preparation of all modules and exhibits for development and commercialization 
• Label negotiations
• Designations (such as Orphan Drug, Fast Track, and Breakthrough) 
• Regulatory Maintenance (periodic reports and amendments) and US Agent services

We also advise in connection with negotiations with and submissions to regulatory authorities in major ex-US markets, including UK MHRA and EU EMA.

Regulatory compliance is a broad set of activities and challenges, but Kinexum experts can help you with compliance audits and quality systems, particularly regarding Chemistry, Manufacturing and Controls (CMC), clinical site audits, and medical device design histories and other compliance and quality system needs.