Continued Expansion of Chemistry Services at MET
Changes to ISO 10993 and the implementation of the MDR, coupled with intensive activity in biosimilars development is driving an increased need for ISO 10993-18 and extractables and leachables testing studies.
Medical Engineering Technologies has further strengthened its knowledge and skill base with the recruitment of Vipul Vaghela. Vipul came to us from Catalent. He is a seasoned veteran of pharmaceutical, analytical chemistry. He as many years of GLP and cGMP experience gained at GSK, Mylan and Bristol Laboratories.
Our labs at MET provide complete testing to ISO 18562 for breathing components, BPOG for pharmaceutical production, ISO 10993-18 (combined with Biological Evaluation Plans) for medical device biocompatibility and E and L studies for pharmaceutical containers. These services are offered as complete projects including: initial investigations, protocol development, method development, chemical analysis and toxicological risk analysis.