We have acted as Contract Head of Quality for clients and supported operational QA work of our clients with our broad knowledge of biotechnology and traditional pharmaceutical manufacturing processes.
We have worldwide auditing experience and current, detailed knowledge of the global regulatory authority requirements (FDA, EU, Japan). We provide our clients with comprehensive, high-quality audit reports 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 QA consulting team has performed and supported pre-approval inspections, supplier qualification, routine and for-cause GMP audits, and inspection readiness and programs.
We have reviewed and improved our clients SOPs, forms, Quality Policy manuals, and entire Quality Management Systems. We have also developed complete lean and phase-appropriate Quality Management Systems for pre-clinical and start-up clients.