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.

Quality Control and Quality Assurance

Protocol generation testing of novel raw materials
Protocol review for qualification and/or testing of raw materials
Microbiological equipment evaluation
Microbiological equipment qualification (Generation of IQ/OQ/PQ documents)
Review of SOP for QC Microbiology, QC Chemistry, and Quality Systems
Data review and/or approval
Technical document generation – trend reports, directions for use, SOP, regulatory submission sections
QC Laboratory and QA System audits
Conduct full Out of Specification or Non-Conformance Report (NCR) investigations and issue associated reports
Trend OOS or NCR data
Establishing quality metrics (turnaround time, on-time completion, error rate, etc)
Starting a new laboratory? We can help design, equip, staff and establish all written procedures.

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.