Regulatory Support

regulatory-support

The impact of regulatory standards on investigators can be overwhelming.  At the PTRU we understand that helping to alleviate this burden is essential to our mission of efficiently and effectively translating high quality preclinical research into successful clinical trials.

For this reason, we provide our partners with regulatory guidance and quality assurance support in all aspects of clinical research ensuring smooth transition from preclinical requirements to first-in-human studies and beyond.  Our goal at the PTRU is to provide our partners with any and all regulatory support needed to navigate their research through the complex regulatory pathways necessary to translate their research onto successful clinical trials.  We offer specialized expertise in:

  • Regulatory strategy development
  • IND/IDE preparation, application, and maintenance
  • GCP/GLP/GMP requirements
  • FDA, IACUC, and IRB regulatory requirements