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
Innovative Science Overcomes Formulation Challenges
Innovative Science Overcomes Formulation Challenges
Partnering to Advance Therapy for Radiation Exposure
Partnering to Advance Therapy for Radiation Exposure