ISI’s Regulatory Strategy Department provides cutting edge, scientifically based, yet realistic strategic regulatory consulting with the goal of getting drug, biologic, device, cosmetic, and generic products to the global market and keeping them there.

About Us

ISI’s regulatory strategists have strong scientific backgrounds, extensive experience leading submissions teams, strong working relationships with regulators, and a proven track record of success with product approvals. Our strategists serve in leadership roles in professional organizations such as Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS). Our regulatory strategists have written best practices guidelines for conducting successful Agency meetings and preparing meeting background packages and have presented at a multitude of professional meetings. ISI also has an extensive network of physicians, ex-FDA reviewers, key opinion leaders, and scientists who can provide targeted guidance and specialized scientific expertise.

What We Offer

ISI’s strategic regulatory consulting team provides the following offerings:

• Regulatory project leadership
  • Expert project leadership and strategic planning for global regulatory submissions (eg, IND, CTA, ANDA, NDA, BLA, MAA)
  • Have worked with both small and large pharmaceutical companies and understand that each client and each application is unique
  • Have successfully led project teams which have included sponsors, partnership companies, third party vendors, key opinion leaders, and academic institutions
• Regulatory component authoring
  • Skilled authorship of regulatory submission components designed with the reviewer in mind, including:
    • Cover letters
    • Forms
    • Responses to Agency requests
    • IND/NDA/BLA annual reports
    • Product labeling (traditional and PLR format, medication guides)
    • Risk management plans (US and EU)
    • Scientifically-based expert reports
• Strategic guidance, portfolio management, and product development planning
  • Design CMC, nonclinical, and clinical development programs
  • Work with industry experts, key opinion leaders, and regulators to ensure that development is robust, streamlined, and cost effective
  • Tailored to each client's business goals. All recommendations are based on:
    • Review and synthesis of the developmental path and approval history of currently approved products
    • Evaluation of products currently in development for the same/similar indications
    • Expert knowledge and experience with the global regulatory environment
    • Estimate of cost and timeline drivers
    • Estimate of probability of success
• Agency meetings
  • Develop ideal meeting questions
  • Prepare and review effective background packages
  • Attend and/or facilitate PDUFA and other meetings with FDA
  • Conduct post-meeting follow-up activities
  • ISI staff have authored “best practices” guidelines on conducting successful agency meetings and reprints are available upon request by clicking here.
• US Agent capabilities
  • Serve as US agent for ex-US companies, virtual companies, and small pharmaceutical/biotechnology companies
  • Have strong working relationships with FDA
• Global strategic regulatory capabilities
  • In formal partnership, work with regulatory experts around the globe to provide on-the-ground regulatory support in all major markets outside the US