GHP December

38 | ghp December 2016 Animal & Health Universal Registration Support inks have been established with a number of public and private research centres to constitute a unique network of competence in the field of animal health. In addition, TransPharm has fostered professional business relations with more than 40 other consultants in the field of veterinary drug registration throughout Europe, as well as some other parts of the world. The services offered to TransPharm’s clients, numbering approximately 30 pharmaceutical companies, include: • project evaluation, and the definition of the requirements to build a registration dossier; • preparation of study protocols, and searching for partners (university laboratories, Contract Research Organisations) to perform the studies required. Fields of interest cover the whole range of studies required in a registration file, from validation of impurities in the raw material (Active Substance Master File) to not only toxicology (core business) but also other activities including pharmacokinetics, microbiological studies, clinical efficacy, etc.; • follow-up of the studies as Study Monitor on behalf of the sponsor until the final study report is approved; • drafting expert reports in the field of Quality, Safety (including Residue File), Efficacy for national, mutual recognition or centralised procedures. The most recent tools in statistical and mathematical model are available in-house to allow the most recent concepts of toxicokinetics, pharmacokinetics/pharmacodynamics modelling or dose-related quantitative effects to be developed; • constitution of registration dossiers and submission to the authorities on behalf of the Applicant. TransPharm is a 100 per cent independent, privately-owned company, which was founded in 1995 by Dr. Pascal Richez ( Veterinary Toxicologist of the Year - Europe). The company has its headquarters in the south of France, close to the university of Montpellier, a home and place of study to in excess of 75,000 students. TransPharm is dedicated to the veterinary pharmaceutical, biocidal and feed additives industry and its main business is focused on drug/additive/biocide registrations in the OECD countries. Other areas of interest are related to veterinary pharmaceutical technology transfers between companies or from universities to industry. TransPharm is thus the partner of the veterinary pharmaceutical and nutritional industry to ensure full assistance “from drug discovery to drug registration”. Dr. Pascal Richez is Senior Consultant and Chairman, TransPharm and member (past-President) of the Association of Veterinary Consultants. Graduated from the Veterinary School and the School of Agronomy in Toulouse (France), he qualified as European Specialist in Veterinary Pharmacology and Toxicology (ECVPT). He has been involved in numerous Quality, Efficacy and Risk Assessments as Consultant for the veterinary drug and feed additive industry. Being primarily involved in coordination and supervision of research programmes to perform risk/benefit assessment and develop PK/PD models, he also participates in working groups for the establishment or revision of guidelines and acts as Member of the Education and Residency Committee of the European College of Veterinary Pharmacology and Toxicology. Dr. Pascal Richez was previously involved in national and private research institutes, such as the National Veterinary School of Toulouse (Dept of Physiology and Pharmacology), the National Agronomic Research Institute, CiToxLAB at Evreux and the Sanofi Research Centre in Montpellier. Company: Transpharm Name: Dr. Pascal Richez Email: [email protected] Address: BP7, 42 Chemin des Olivettes, 34160 St Genies des Mourgues, France Telephone: +33 6 72 21 17 95 L