We design comprehensive regulatory strategies for preclinical and early clinical development and provide assistance in interactions with FDA and preparing IND filing.

We have a strong record of accomplishments in:

• Preparation of summary documents for regulatory submissions
• Investigator Brochure creation
• IND preparation and review
• Preparation for FDA meetings

Our medical devices' services include:

• 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)