Our Solutions

Scientific, Regulatory and Strategic Guidance

Once your needs have been clearly identified, we prepare study designs that best accommodate your development needs while ensuring effective study conduct. In addition, we provide the highest quality regulatory support in order to help you meet key preclinical and clinical study milestones.

Regulatory Support

Our experienced regulatory team consistently produces high quality submissions, ensuring key study milestones are met on time and that study goals meet the requirements of corresponding authorities. Our regulatory support services include:

  • Clinical Trial Application (CTA) and Regulatory Application preparation and submission
  • Coordination with regulatory agencies for pre-trial submission meetings
  • Coordination of IRB submission
  • IRB submission, preparation of pre-CTA and pre-IND packages
  • eCTD-compliant format
  • International guidelines experience (TPD, FDA, EMA, TGA, ANVISA)
  • Consultants available as needed to provide additional expertise

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