Pass the inspection. Protect the business.
Led by a former primary FDA contact for a regulated pilot plant, with IT compliance led by a U.S. Navy veteran.
- FDA inspection readinesscGMP Readiness Assessment, mock inspections and MoCRA checks.
- Form 483 responseRoot cause, CAPA and a response inside the 15-business-day window.
- Purified waterReviews and root-cause help for USP water systems.
- Cybersecurity & IT complianceRisk assessments, NIST and CMMC readiness, policies and audit preparation.



