Regulatory Support

REGULATORY SUPPORT

Quality Program Design and Strategy

We provide thorough quality systems design and planning services to companies in the Dietary Supplement Industry looking to 1) develop or evaluate their own in-house Quality Program, 2) transition to/from third-party testing labs or 3) develop and implement a combination strategy to reduce costs.

  Structure Function Claims
  Technical Documentation Development and Training
  SOP and Master Control Documents
  Best Documentation Practices
  FTC Action, FDA Inspection Support and Response Letters

We can support you in the event of an onsite inspection by the FTC or FDA or other regulatory body assessing your state of compliance. For pre-approval inspections, we can provide audit walk-through’s to identify the critical elements of your Quality System that are potential liabilities.

Upon inspection with the FDA, if you received corrective orders or 483 Observations, we can work with you and your team to prioritize and implement the necessary corrective actions, including FDA Inspection Response Letters.

Ingredient Filings (GRAS, NDI, etc.)

We provide comprehensive review and/or drafting of applications for ingredients to be classified as Generally Regarded as Safe (GRAS) or New Dietary Ingredients (NDI). We also provide strategic review of your product for ingredient to best position the product for its’ intended purposes or market with respect to relative regulatory requirements.