THE R&D LABORATORY THAT BOOSTS YOUR DEVELOPMENT PROJECTS

Transcription

1 THE R&D LABORATORY THAT BOOSTS YOUR DEVELOPMENT PROJECTS

2 CREATED IN 2011 WITH A PROVEN EXPERTISE IN AUDIT AND REGULATORY AFFAIRS, BIOLABEX NORTH AMERICA PARIS EUROPE ASIA EXTENDS ITS OFFERINGS AND IS NOW A GMP COMPLIANT LABORATORY PERFORMING CDMO (CONTRACT DEVELOPMENT & MANUFACTURING ORGANISATION) AFRICA ACTIVITIES. FROM EARLY DEVELOPMENT TO CLINICAL RESEARCH, BIOLABEX IS YOUR STRATEGIC SOUTH AMERICA MADAGASCAR MAURITIUS PARTNER THAT BOOSTS AND SUPPORTS YOUR DEVELOPMENT PROJECTS IN COMPLIANCE WITH AUSTRALIA INTERNATIONAL STANDARDS. A STRATEGIC GEOLOCALISATION RESEARCH ACTIVITIES FORMULATION CONCEPT MARKETING Strategically located in Paris and Mauritius, BIOLABEX assists you in sourcing active ingredients from one of the international biodiversity hotspots, to marketing your products on global markets. SOURCING OF ACTIVE INGREDIENTS ANALYTICAL CHEMISTRY IN VITRO STUDIES CLINICAL RESEARCH 3

3 AN INNOVATIVE APPROACH WITH OPEN PERSPECTIVES A CENTRE OF EXPERTISE A unique sourcing from a rich biodiversity Located in the heart of the Indian Ocean and close to Madagascar, BIOLABEX provides sourcing of active ingredients from a rich biodiversity for R&D activities. All services in one place At its headquarters in Mauritius, BIOLABEX is a key player in the fullfledged services proposed by the BioPark Mauritius, which brings together the most successful biotech companies. BioPark Mauritius is a combination of three complementary expertise: CIDP, an internationally recognised Contract Research Organisation QUANTILAB, a laboratory specialised in analytical microbiology, organic chemistry and inorganic BIOLABEX, the first GMP compliant CDMO (Contract Development and Manufacturing Organisation) of the Indian Ocean An easier commercialisation Its dual presence in Paris and Mauritius enables BIOLABEX to act as a hub in a globalised world. EARLY DEVELOPMENT BIOLABEX meticulously selects and valorises active ingredients. It offers a one-stop-shop with time and costs advantages for Proof of-concept and Proofof-Mechanism (POC / POM) studies: Production of clinical batches usable within 24 to 48h - Reduction of costs and timeframes related to stability studies Analytical and microbiological control Pre-clinical and clinical trials FORMULATION Depending on your specific needs, BIOLABEX offers a comprehensive range of formulating services which include assisting you in the formulation and the valuation of active ingredients. MANUFACTURING As the first GMP compliant laboratory in the Indian Ocean, BIOLABEX takes advantage of its geographical position and acts as an optimal manufacturing platform for the pharmaceutical and cosmetics industries. We maintain high quality standards with an attractive overall cost. CONCEPT MARKETING In addition to the valuation of active ingredients, we provide the best in terms of conceptualisation of marketing strategies aiming to achieve your business objectives. We also provide various means and resources which includes bibliography and pictures to help you in your marketing endeavour. REGULATORY We offer a suite of services designed to facilitate the regulatory requirements of your company; registration of your products, managing all your documentation (Notifications, DIP, INRS registration, AMM files), assessing your raw materials/ingredients and finished products (safety, regulatory and toxicological compliance), setting up or assessing cosmetovigilance and pharmacovigilance with stepwise follow-up process (AEs and SAEs) and controlling advertising (visa PP). AUDIT We help ensure that your systems are to the highest standards. We provide expert services including compliance audit of your Quality system in accordance with International Standards (GLP, GCP, GMP, ISO standard) as well as your Internal Standards. We qualify service providers and act as a support for the management in terms of quality. BIOLABEX is close to its main clients, leading players in the pharmaceutical and cosmetics industries in Europe and US, and at the crossroad of two promising markets, Africa and Asia. 5

4 A POOL OF EXPERTS A SET OF COMMON VALUES MARC LABICHE PHARM D Chief Executive Officer Marc Labiche is the CEO of BIOLABEX. In this role, he is responsible for leading all the activities and also also guaranteeing tailored high quality services to his clients. He has over 25 years of experience holding executive leadership positions internationally related to pharmaceutical, cosmetics, R&D and Manufacturing. He is a Quality GxP expert and is well-versed with GLP / GCP / GMP / GVP/ GDP / ISO and ISO Audits. Marc holds a PhD Pharma from University of Pharmacy of Grenoble and a Master in industrial Pharmacy from IPIL (Institut de Pharmacie industrielle de LYON). QUALITY COMMITMENTS We demonstrate our quality commitments and dedication through continuous improvement in compliance to client specifications & timelines, regulations and GxP (GLP, GCP, GMP). HEALTH & SAFETY We care for the welfare of our team: A well-established and comprehensive health and safety policy With their different backgrounds and knowledge gained from Europe, US and Asia, the team member s mission is to develop the best solutions for the business needs of clients. As an innovative company, BIOLABEX believes that investing in people and their well-being is fundamental for its future success. Suitable and efficient equipment designed for safety purposes A fully trained team on the latest Health & Safety prerequisites. AN AVANT-GARDE ENVIRONMENT Located in Paris and Mauritius, BIOLABEX offers 500sqm GMP compliant laboratories with strict segregation between pharmaceutical and cosmetics activities. Facilities are designed: ISO 7 standard clean rooms equipped with Bio Safety Cabinet (BSC, ISO 5 standard) for pharmaceutical manufacturing allowing controlled airborne particles rate due to HVAC technology 70sqm of formulation lab with state-of-the-art equipment for your research development and stability assays To strictly control the temperature, hygrometry and pressure SOCIO- ECOLOGICAL We believe in working conditions that respect the environment and the community. We have invested in an innovative eco-building, in a solvent recycling system and in an organic and inorganic waste management. To ensure the safety of operators while offering high-quality products To protect API & environment (inactinic light, waste management, HEPA filters, active carbon air filter ) 7

5 Mauritius BioPark Mauritius, Socota Phoenicia Sayed Hossen Road, Phoenix 73408, Mauritius. Paris +33 (0) , rue des Meuniers, Bagneux, France. info@biolabex.com biolabex.com