Regulatory Strategy and Management

Regulatory strategy begins with an understanding of the relevant regulatory pathway, and which FDA Center/Division the client may prefer  to have jurisdiction, from among available options, if any.  Perhaps your product candidate targets the 505(b)(2) NDA for a new formulation or new indication for an approved drug; or perhaps the biosimilar pathway. Your device may be (risk level) Class 2, eligible for a Premarket Notification under 510(k), or if there are no predicate devices, perhaps a Class 3 de novo that could convert to a Class 2 device pursuant to a 510(k) with special conditions, or the more comprehensive Premarket Approval (PMA). While emerging companies typically want to select the quickest route to regulatory clearance or approval, it may be possible that more value can be created by a higher risk classification that creates a greater barrier to entry to competitors. 

Kinexum experts can guide you through considering and deciding regulatory strategy, then we can help you with execution, 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 
  • Gap Analysis 
  • Preparation for FDA Meetings (e.g. pre-IND, INTERACT, pre-sub, End of Phase 2 Meeting, etc. (including Meeting Requests with questions and Informational Packages) 
  • Submissions (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, commercialization 
  • Designations (such as Orphan Drug, Fast Track, and Breakthrough) 
  • Regulatory Maintenance (periodic reports and amendments) and US Agent services