Evotec (UK) Ltd

Thursday, February 22, 2007 Print

Evotec offers a complete service for the synthesis, formulation, manufacture and regulatory requirements of your drug candidate through preclinical development, clinical trials and onto the market. Our fully integrated, state-of-the-art analytical and development facilities have supported more than 200 partners from both the Pharmaceutical and Biotechnology industries. With over 150 staff dedicated to development, we go beyond simply providing your drug product by offering a full consultancy service, with complete project management at every stage of the process. Skills & Expertise CUSTOM PREPARATION - Lab-scale cGMP and non-GMP custom synthesis - Access to sophisticated and wide ranging chemistries PROCESS RESEARCH & DEVELOPMENT (PRD) - PRD services to reduce the number and complexity of the chemical synthetic steps - Development of processes suitable for large scale manufacture - Route development ANALYTICAL DEVELOPMENT & TESTING - Full analytical services for IND/NDA - Method development - Method validation - Stability studies PRE-FORMULATION PACKAGE - Full range of pharmaceutical services including salt selection, polymorphism studies and pre-formulation testing - Identification of the appropriate formulation strategy for the drug candidate PILOT PLANT - Clinical trial material of up to several hundred kilos can be manufactured to support Phase I - III clinical trials - Manufacture of commercial supply material as well as non cGMP material for toxicity studies - FDA and MHRA inspected pilot plants - Certified to ISO14001 environmental quality standard - Provision of CMC sections to support both IND/CTA and - NDA/MAA submissions DRUG FORMULATION & MANUFACTURE - Expertise in developing liquid or lyophilised formulations for small molecules and biologicals including proteins, peptides, and antibodies - Manufacture of liquid or lyophilised aseptic batches of small molecules and biologicals for clinical trials, including cytotoxics - In house Qualified Person (QP) release of clinical trial materials