Regulatory Support for Drugs and Medical Devices

We design comprehensive regulatory strategies for preclinical and early clinical development, and we also provide assistance in interaction with the FDA and preparing IND filing.

These services include:

  • preparation of summary documents for regulatory submissions
  • investigator brochure creation
  • IND preparation and review
  • preparation for FDA meetings
  • review and gap analysis of nonclinical and clinical data
  • biocompatibility evaluation (ISO 10993 and G95-1) and report writing
  • preparation of documentation for regulatory submissions (510k, PMA)