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)