Our regulatory colleagues are fully versed in the current requirements for all types of regulatory submissions, including Clinical Trial Applications (CTAs and INDs), New Drug Submissions (NDS), Supplemental NDS, and briefing booklets in preparation for Pre-CTA and Pre-IND Meetings. All documents are prepared using the Common Technical Document (CTD) format.

In addition, the team can evaluate your pre-clinical, clinical and chemistry data for approval by the regulatory authorities and assist with the preparation/rehearsal for pre-submission meetings.

Our well-established contacts with the regulatory agencies ensure that your regulatory questions are answered promptly and accurately at all times.