Pharmaceutical Development Services (PDS) is a pharmaceutical and regulatory consultancy serving the pharmaceutical,biopharmaceutical, medical device and cosmetic industries. We provide expert advice on drug development and production strategy including the development, supply and regulatory control of new and existing pharmaceutical products.
PDS was formed in 2000 and now boasts a staff of 10. We have an extensive network of consultants who provide detailed and up to date specialist technical knowledge when required for a particular project. PDS consultants also work as experienced interim managers for senior positions in Regulatory Affairs, Pharmaceutical Development and Quality Assurance.
We opened our US office in June 2009 to assist US-based companies in bringing their development and licensed products into the European Union. We offer a complete service in this area including legal, regulatory and quality assistance. Please contact our US Business Development representative for further information.
Website address www.pharmdservices.com
PDS consultants work with a range of clients from small start- up biotechnology companies to large multi-national pharmaceutical companies. An increasing number of clients are located overseas.
PDS consultants assist companies in the placing of work with CROs from the preclinical stage to Phase 3. This involves CRO selection for particular projects depending on their skills. They also advise on CRO management issues and how to avoid the pitfalls on contracting out technical work.
Our experienced consultants audit laboratories and manufacturing facilities, including contractors for clients. All consultants have in-depth knowledge and experience of their technical areas. Audits can be performed according to GMP, GDP and GCP guidelines. PDS can advise on quality assurance strategy, and also provide preparation for pre-approval and other regulatory inspections. PDS offers a contract QP service, with staff who are eligible for nomination as QPs under the permanent provisions of 2001/83/EC and 2001/20/EC, and who are able to QP release both commercial and investigational medicinal products.
PDS advises companies on the strategy for introducing a new product, from pre-clinical technical development to a multi-national commercial launch. This involves project management, due diligence, production strategy, launch strategy, technology transfer and regulatory issues. This ensures that a new product is launched which meets all of the requirements and is marketed properly with the right amount of product in the right place at the right time.
PDS provides strategic regulatory advice and support for agency submissions, due diligence and writing regulatory dossiers through to dealing with responses from regulatory authorities after submission of the dossier. As well as small molecules and botechnology compounds, PDS also has expertise with herbal medicines, nutraceuticals, cosmetics and medical devices.
We also offer an Expert Witness service, for advice and guidance on the resolution of legal disputes. These can range from formulation, safety, control and regulatory issues pertaining to patents.
We provide expert in-house and public training courses through our sister business PharmaTraining Services (www.pharma-training-courses.com). See the website for our current training services or call Michael Gamlen to discuss your in-house training requirements.
PDS always welcomes informal enquiries and will be happy to speak to you.
We look forward to hearing from partners interested in developing, registering and supplying small volume products including paediatric dosage forms. We offer an all-inclusive, full product development, registration and supply service.
Dr Michael Gamlen
Clients in focus...