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)