French Ministry of Research Approves NextPharma Technologies as a Contract Research and Development Organization Carrying out R&D Activities on behalf of French Companies
3/1/2010 2:04:59 PM
Surrey, UK, 1st March, 2010 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, is pleased to announce that the French Ministry of Research (Ministere de l’Enseignement Superieur et de la Recherche) has approved NextPharma as a contract research organization (CRO) carrying out innovative R&D activities for French companies at NextPharma’s Sterile Product Development Center. This approval enables companies subject to corporate tax in France to claim tax credits (Crédit d'Impôt sur la Recherche) for work subcontracted to NextPharma.
NextPharma which already has a track record of successful collaborations with French pharmaceutical and biotechnology companies received approval from the French Ministry of Research by presenting a recent development project that demonstrated significant innovation as a subcontractor in the development of a sterile, controlled-release formulation. Accreditation is awarded by the French Ministry of Research to companies who have demonstrated “originality or substantial improvement” in the creation or improvement of a product or process and is an official recognition of NextPharma’s capacity to offer pioneering solutions as well as bespoke product development services.
Sean Marett, Managing Director, NextPharma Technologies, Product Development Services (PDS) commented: “We are very pleased to have received this approval and as a result look forward to continuing to serve French pharmaceutical and biotech companies as we combine innovation with our product development expertise and our clients’ ability to claim tax credits”.
Bill Wedlake, CEO NextPharma commented: “We are delighted to have received this official recognition from the French Ministry of Research, we have a number of eligible French private companies amongst our client base and we are pleased that this approval will support their business growth through development work outsourced by them to NextPharma”.
NextPharma PDS operates globally with seven centers of excellence in Europe and North America. PDS services include preformulation studies, formulation development, design, development and optimization of lyophilisation cycle, manufacturing for clinical trial materials, analytical and microbiological testing, clinical trial labeling and kitting and stability testing according to ICH guidelines as well as regulatory support and product dossier development and registration.
Our expanded sterile businesses now includes sterile product development and manufacturing capabilities in both San Diego, California and Braine-l’Alleud, Belgium where we are able to support non-clinical through clinical development of sterile products including biologics and cytotoxics. In addition, our San Diego facility is ISO 13485:2003 certified for medical devices and manufactures medical devices with batch sizes spanning the needs of research and development through to commercial quantities of product.
Our world class PDS team provides clients with the confidence and knowledge that your products will be produced to meet your exact requirements. Customer satisfaction is a key importance to NextPharma: each customer receives a dedicated project manager responsible for managing the development project within NextPharma and ensuring the highest level of customer service. As products transition from development to commercial scale, we are able to provide a seamless process from non clinical product formulation to commercial scale manufacturing, either within NextPharma, or if the customer requires to another company of their choice.
NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
We offer a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing. We are a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Our sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally we have significant expertise in paediatric drug formulation, development and manufacture. NextPharma offers ‘one-stop’ logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP/GDP regulations.
We operate globally with seven product development centres, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
We have 1,200 employees dedicated to serving over 200 customers world wide and a customer base, which includes many of the world’s leading pharmaceutical, specialty pharma and biotech companies.
We have a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of our sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.