Regulatory Strategy and Management

Regulatory Strategy and Management


Kinexum's Regulatory services include:

Regulatory Strategy and Services – Biotech and Pharma

  • Strategic guidance for new drug, biologic and biosimilar development including execution of the strategy in partnership with the sponsor
  • Review, write and submit regulatory submissions (pre IND,  end of phase II, Type C meeting, briefing packages, IND, meeting requests,  Annual Reports, white papers, etc) to multiple divisions within the FDA.
  • Identification of all pertinent procedures, guidances, regulations, and laws  
  • Gap analyses and diligence
  • Clinical and nonclinical development strategy  
  • Biosimilar development expertise
  • Participation in FDA meetings to supplement clinical, CMC, nonclinical, and regulatory capabilities  
  • Emergency steps to resolve IND holds and FDA comment letters
  • Access to specialized and respected experts across scientific, technical, biostatistical, legal, and commercial fields


Regulatory Strategy - Medical Device

  • Medical device and diagnostic product profiling, competitive landscapes, orphan designation, combination products
  • US and International regulatory strategies and tactics, gap analyses, developmental risk assessments
  • Integrated global registration approaches
  • Design and preparation of meetings, advisory panels, and other important communications with U.S. FDA review divisions and policy makers and other international authorities
  • Design, production oversight, and/or critique of regulatory documentation: IDEs, 510(k)s, PMAs and annual reports
  • Response to regulatory emergencies such as product recalls and clinical holds
  • Due diligence
  • Regulatory climate forecasting and anticipated expectations


Regulatory Operations Management

  • Interpretation of regulatory policies, FDA and EMEA
  • Act as agent (sponsor representative) to the FDA
  • Written and oral communication with the FDA
  • Organization and participation in FDA meetings (meeting minutes, follow up correspondence)