Strategic Product Development

Clinipace Worldwide has been providing a full complement of solutions to growth- and mid-stage biotechnology, pharmaceutical, and medical device companies for nearly ten years.

Through Regulus Pharmaceutical Consulting, a division of Clinipace Worldwide, we provide:

  • Strategic Development
  • Regulatory Operations (e-publishing)
  • Quality Assurance
  • Medical/Scientific Writing

Our goal is deliver all the services needed by these companies from early-stage regulatory development consulting to clinical development, and electronic filing of an eCTD.

The Clinipace Worldwide Regulatory and Strategy Development (RSD) team helps clients move their products from the lab to market while containing costs, reducing time and minimizing risks. We construct a detailed strategic plan along with a budgetary analysis so your projects stay on track and your investors are well-informed. Additionally, the RSD team is regularly contracted for due diligence work on licensing and acquisition transactions in the life sciences.

Clinipace Worldwide has extensive pharmaceutical, biotechnology, and medical device knowledge, with an average of over 15 years’ industry experience, members of our team can provide expert advice covering nonclinical to clinical activities to manufacturing, marketing, and post-marketing support. And, our in-house publishing group can prepare electronic or paper dossiers for worldwide regulatory submission.

Our Quality Assurance team provides quality systems consulting for all aspects of pharmaceutical and dietary supplement product development, from assistance with the implementation of US FDA and ICH-compliant GMP, GCP and GLP regulations through to the design and establishment of quality systems.

Our medical writers that can produce documents for all stages of clinical development including literature summaries, pre-FDA meeting briefings, regulatory filings, protocol development, Common Technical Documents (CTDs), case report forms, clinical study reports, , investigator brochures and annual updates, informed consent forms, and IRB communications, DSMB reports, and scientific abstracts, manuscripts, and journal articles.