For Pharmaceutical Manufacturers
Medical innovation continues to be an extremely important aspect to the health of our communities and global population. As part of this process, evaluating pharmaceutical products for manufacturing quality, efficacy and safety are core requirements for bringing a new product to market. The product’s characteristics can be understood through analytical testing, and accurate analytical results form the foundation of establishing safe, pure and high quality products.
Bureau Veritas is trusted by customers worldwide to provide expert analytical testing throughout the regulatory process. We provide contract analytical services in support of pharmaceutical product manufacturing, research and development, and quality control. Our dedicated and experienced team acts as a seamless extension of your analytical R&D and Quality Assurance groups.
Customers rely on Bureau Veritas to provide a variety of analytical testing services to identify, qualify and report product- and process-related impurities to meet regulatory requirements. Services include analysis of Active Pharmaceutical Ingredients (APIs), raw materials testing, and clearance and control of additives.
Our analytical experience includes a diverse range of products including peptides, metallo-drugs, medical devices, nutraceuticals, excipients and packaging materials. We routinely test pharmaceuticals for elemental impurities (USP <232> and <233>, ICH Q3D), residual catalysts (ICP-MS), and evaluate product stability and dissolution.
Additional biologics and biopharmaceutical testing services include:
- Process impurities and additives
- Silicones and antifoams (final bulk product)
- Silicon and tungsten (glass syringes)
- GLP extractables/leachables studies (design and implementation)
Our state-of-the-art laboratory is equipped with a comprehensive inventory of instruments and is externally audited and inspected on an ongoing basis.