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Strategic and Regulatory Expertise

Full Access to Dedicated Strategic and Regulatory Expertise

PD® Laboratories’ vaccine sciences lab brings together our strategic and regulatory expertise to offer comprehensive services that streamline vaccine development, clinical trials and regulatory approval.

We have demonstrated success with regulatory agency filings, inspections and development of regulatory guidelines and best practices.

PPD Laboratories provides regulatory consulting for clinical studies, pharmacovigilance and post-approval label claim studies. Our strategic and regulatory expertise includes:

  • Preclinical research and epidemiology studies
  • Early clinical trials (safety and proof of concept with lab endpoints)
  • Phase III pivotal efficacy studies (clinical and lab endpoints)
  • Post-approval studies (expanded label indications, safety surveillance, registration studies)
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