Food and Supplement Consulting

HACCP Plan and Food Safety/Defense Plan Development, Dietary Supplement Formula development, review, and assessments for label claim verification.

Experts certified in HACCP hazard analysis & certified SQF practitioners available

Auditing & Regulatory Affairs Compliance

Verification that Due Diligence has been applied.

Including pharma, medical device, and food GMP environments as described by Title 21 CFR § 111, 117, 211, 820 for manufacturing, storage, and laboratory operations.
Priority response and support for FDA citations, warning letters and Form 483. Management system Gap assessment and agency CAPA response.
Experienced CDMO management including supplier qualification, surveillance auditing, and for-cause auditing.
Management of custom starting material manufacturing, advanced intermediates, and APIs.
Equity Due Diligence. Assessment of management control systems and elucidation of potential risks, opportunities, and liabilities.