Rephine helped transform our facility into a GMP compliant site ready for FDA inspection. Their expertise not only ensured compliance but also gave our teams the knowledge and confidence tosustain high-quality standards as we expand into OTC product manufacturing.
Client Testimonial
About this Case Study
A global cosmetics manufacturer, aiming to expand into the pharmaceutical space with over-the-counter (OTC) products, faced a critical challenge: achieving compliance with stringent US GMP (21 CFR 210–211) and FDA requirements. With limited internal GMP expertise, the site needed end-to-end guidance to prepare for inspection readiness and sustainable compliance.
Rephine partnered with the client to deliver a 12-month programme covering gap assessment, remediation, compliance readiness, and knowledge transfer. The result was a facility transformed into a GMP-compliant, FDA-ready site with empowered teams and a strengthened quality culture.
Key outcomes included:
- Successful FDA inspection readiness and site qualification for OTC production
- Expanded market access through new product opportunities
- Enhanced GMP knowledge and reduced compliance risks
- Sustainable quality culture embedded across departments
✅ Download the full case study to discover:
- How Rephine guided the site through GMP gap assessment and remediation
- The strategies used to achieve FDA inspection readiness within 12 months
- How compliance maturity enabled long-term growth and market expansion
Result: A compliant, inspection-ready site enabling OTC manufacturing and new business opportunities.
Download the Case Study
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