Preclinical Development Plans and Regulatory Services | SRI International

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Preclinical Development Plans and Regulatory Services

Navigating the drug development process from early discovery to Phase I clinical trials can be complex and costly. Success requires a well-organized preclinical development plan.

To guide clients to a successful Investigational New Drug application (IND), SRI's Pharmaceutical Regulatory Services team partners with pharmaceutical and biotechnology companies, universities, and the government to prepare for Phase I-enabling studies. SRI researchers prepare, review, deliver, and follow the progress of the preclinical development plan and the documentation required for clients' pre-IND and IND submissions to assure compliance with Food and Drug Administration (FDA) regulations and protocols.

SRI can help you to

  • Refine preclinical program objectives

  • Develop a regulatory strategy

  • Review data and perform gap analyses

  • Design preclinical development testing to support an IND application

  • Design a risk management and contingency plan

SRI can create a Preclinical Development Plan (PDP) that defines a specific strategy and the study outlines to advance your lead candidate from the discovery stage to IND submission and initiation of Phase I clinical trials.

SRI's Regulatory Affairs Department can also

  • Provide drug/device development project management

  • Assist in preparing your organization for a pre-IND meeting with FDA

  • Prepare, assemble, and index an original IND for FDA submission

  • Coordinate and assemble the manufacturing, preclinical, and clinical documents for review and prepare an IND application

  • Prepare and update Master Files

  • Prepare and update Investigator's brochure

  • Prepare Annual Reports

  • Provide additional submissions and amendments as necessary for successful filling and maintenance of an IND

Marketed drugs discovered at SRI—proof of successful outcomes—include:

  • Bexarotene, for the treatment of cutaneous T-cell lymphoma

  • Halofantrine, an antimalarial drug

  • Pralatrexate, for the treatment of peripheral T-cell lymphoma

  • Vidarabine, an antiviral drug

Projects

Innovative Science Overcomes Formulation Challenges

Innovative Science Overcomes Formulation Challenges

Partnering to Advance Therapy for Radiation Exposure

Partnering to Advance Therapy for Radiation Exposure