Cilatus Manufacturing Services has a broad and deep experience in auditing and can partner with our clients to provide a comprehensive and high-quality review to ensure compliance with all aspects of EU and US GMP guidelines including Annex 16 for auditing API, Drug Product, Packaging and Laboratory Facilities.

Our team has in depth experience of clinical and commercial product types including small and large molecule Drug Substance/API, Solid Dose Processing, Sterile Filling of Vial and Syringe formats and multiple Packaging formats and extensive Quality Control and Quality Assurance expertise for each of these supply chain stages.

Our team has experience of performing auditing in multiple countries globally and have detailed knowledge of global regulatory authority requirements (FDA, EU, Japan). We can assist clients with all of their auditing requirements and have a proven track record in the areas of pre-approval inspections, supplier qualification, routine and for-cause GMP audits, inspection readiness and remediation programs.