Nutraceutical Development Services

IDSC has the years of expertise and on the ground experience to guide our biotech, academic, and big pharma nutraceutical clients through the development process. Because, historically the cost to market has been less, the time to market shorter, and the regulatory hurdles lower, many companies turned to medical foods and other related nutraceutical products to enhance their pipeline and bring novel products to market more quickly.

 

These companies come to IDSC for development, regulatory, marketing, and strategic consulting to enable their nutraceutical programs.  Now that the FDA may be "rewriting the book" for medical foods guidelines, IDSC's expertise is highly valued by our clients.

Many of IDSC services in the nutraceutical and medical foods area are listed under the headings below.  However, in addition to specific consulting services around regulatory & clinical strategy and market assessment, our clients come to us for the following key steps in their development process:

 

  • Draft a program review
  • Draft a gap analysis
  • Draft a preclinical and/or clinical development plan



Click here to view IDSC's Director, Lauren Costantini's white paper entitled "Nutraceuticals:  Emphasis on Medical Foods."



Regulatory Compliance

IDSC's Nutraceutical clients come to us for regulatory support.  We help them:

 

  • Optimize their regulatory strategy
  • Ensure their program activities and goals are aligned with their regulatory strategy
  • Prepare the appropriate regulatory documentation
  • Create and deliver their regulatory submissions
  • Prepare for meetings with regulatory agencies

Strategic Planning

Our directors have years of experience in strategic planning, and in all areas of nutraceuticals (medical foods, suppliments, functional foods, etc), we help our clients by:

 

  • Guiding the development of the company strategy:
    • Establish a business plan integrated across R&D, manufacturing and clinical lines
    • Set and track company goals, timelines, budgets, and milestones
    • Generate an exit strategy
  • Identifying and overseeing external vendors

Training

  • We ensure pharmaceutical companies moving into nutraceuticals gain the needed knowledge to be successful.
  • We ensure our clients have an appropriate understanding of risks, benefits, and regulations around nutraceuticals.

Market Assessment

Our clients come to us for a number of market assessment, due diligence, and valuation services including:

 

  • Evaluate client asset
  • Determine market size and potential market penetration
  • Gather competitive intelligence
  • Position client to manage negotiations with investors/ partners in order to receive highest value for their asset
  • Performing product valuations are not just in the domain of "big-pharma"
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