Experience the Difference

Clinipace Worldwide has managed over 500 contract research and regulatory projects conducted globally working with almost 5,000 global investigator sites enrolling over 125,000 patients.

Clinipace Worldwide has successfully completed hundreds of regulatory projects for its international and North American clients including pre-IND, IND, CTA, IMPD, NDA, BLA, MAA, ANDA, DMF, Orphan Drug, and Packaging/Labeling submissions; FDA meetings and critical negotiations, and GMP and GLP audits, inspections, and remediation plans. The company is also regularly contracted for due diligence work on licensing and acquisition transactions in the life sciences.

We offer unmatched expertise in providing emerging and mid-tier biopharmaceutical and medical device firms strategic product development, technology-driven clinical operations, data management, regulatory affairs, and quality assurance services. With more than 80% of our staff having seven or more years of relevant industry and trial experience we provide exceptional operational, regulatory, and scientific guidance and oversight to your trial.

Additionally, we have extensive experience with regulatory submissions to the US FDA. In the past 3 years we have prepared:

  • 25+ FDA meetings ( pre-IND, EOP2, pre-NDA, SPA meetings)
  • 40+ IND original applications and major amendments to IND
  • 16 major submissions for marketed products to US FDA (sNDAs)
  • Five compete NDA or BLA original applications, including eCTD format
  • Compilation of several sections for NDA applications
  • 17 generic drug submissions to US FDA (minor submissions excluded)
  • Nine Drug Master Files (small molecules, natural product-derived NCEs)
  • Orphan Drug Designation applications

Graph of oncology clinical trials, cns clinical trials, cardiovascular trials

Clinical Trials - Phase 0, Phase 1, Phase 2, Phase 3