Food and Dietary Supplements

The regulatory environment for dietary supplements and food products varies around the world and continues to evolve. Divergent regulatory options need to be carefully considered and chosen based on the complex and extensive requirements for alternative approaches. Spherix Consulting offers the following services:

Study design and oversight

  • Toxicology
  • Create and review SOPs
  • Pharmacology
  • Clinical trials ( I-IV)

Regulatory filings

  • Investigational New Drug Application (IND)
  • 505(b)(1) New Drug Application (NDA), 505(b)(2) NDA, 505 (j) Abbreviated New Drug Application (ANDA)s
  • Combination Products
  • Drug Master Files
  • Compliance planning and strategy
  • Manuscript and report writing
  • Scientific and regulatory due diligence assessments