Experience:
PDS has over 20 years experience in the field of pharmaceutical development for solid dose products. This includes tablet development, stability testing, CMC project and regulatory strategy and implementation. PDS has developed and implemented Chemistry and Pharmacy regulatory strategy for compounds from preclinical phase to NDA/MAA approval.
Project Management:
PDS has proven experience in working with clients to develop their pharmaceutical development, and manages development projects on behalf of clients. This can include working with contractors, identification of project milestones and objective timelines. PDS can establish the maintenance of operational project groups and effective communication channels, and implements project tracking measures and real-time monitoring and reporting.
Production Strategy:
PDS can advise on production strategy for new products in the EU and USA, and provide development and packaging strategies. R&D and Marketing can be advised on the optimum ways of presenting and packaging a product for global supply.
Due Diligence:
Technical due diligence can be undertaken for potential licensing opportunities. This includes chemistry, manufacturing and control, preclinical and clinical due diligence. The transfer of product knowledge from licensor to licensee can be facilitated. 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.
Preformulation Studies:
PDS provides consultancy in preformulation studies, and can advise on all technical issues prior to formulation development.
Further Expertise:
PDS has a network of consultants to enable PDS to have access to a range of expertise and capabilities. This enables PDS to meet demanding client requirements and to fulfil the requirements of projects.
Training and Development:
PDS consultants regularly speak on technical and scientific material at conferences, such as AAPS and the Royal Pharmaceutical Society of Great Britain. The range of in- house expertise enables PDS to present on a range of topics, and presentations are tailored to the requirements of the audience. PDS also run bespoke in-house training courses. These are particularly useful for non EU companies that are intending to launch products in the EU.
Contact:
| Michael Gamlen | Managing Director, Technical |
Experience:
PDS provides strategic regulatory advice and support for agency submissions based on over 20 years of experience in senior levels of regulatory affairs. PDS also provides major regulatory submissions in Europe and the USA, and has established regulatory affairs tracking and management systems.
PDS has experience over a range of product types including pharmaceuticals, orphan drugs, biotechnology products, OTC products, herbal medicines, nutraceuticals, medical devices and cosmetics.
Management:
PDS provides an interim management service for regulatory affairs, such as the temporary replacement for a senior member of staff. PDS assists emergent companies intending to establish a European office and to provide a complete development management team. Specific projects, such as the mutual recognition procedure, can be managed on behalf of clients.
Due Diligence:
PDS provides regulatory due diligence for potential licensing opportunities in chemistry, manufacturing and control, preclinical and clinical research.
Regulatory Strategy:
PDS provides regulatory strategy for new product development in the EU and USA. This includes development strategies in terms of formulation, indications and dosage instructions. PDS can represent companies at meetings with regulatory agencies for novel forms of therapy.
Preparation of Pivotal Regulatory Documents:
PDS routinely prepares regulatory dossiers, CTD pharmaceutical, preclinical or clinical overviews, Mutual Recognition Procedure documents, response documents and briefing documents for pre-NDA or EMEA scientific meetings.
Pharmacovigilance:
PDS is starting a pharmacovigilance service, to reflect the substantial change in the way that the pharmacovigilance responsibilities of the Marketing Authorisation Holder are regulated by the MHRA. This includes the provision of a qualified person for pharmacovigilance.
Contact:
| Michael Gamlen | Managing Director, Technical |
Quality Assurance Management:
PDS provides an interim management service for QA, either as a temporary replacement for a member of staff, or for emergent companies intending to establish a European office. A management service can also be provided for a particular project, such as the development of a new documentation system.
Experience:
PDS staff possess over 20 years of experience at senior levels in Quality Management and New Product Introduction, including technology transfer and industrialisation in Europe and the USA. Members of PDS staff are eligible for nomination under the permanent provisions of EU Directives 2001/83/EC and 2001/20/EC. PDS has proven experience with contractor evaluation and selection, conventional pharmaceutical products, biotechnology and devices. Other projects have included the management of cross-functional teams to transfer global products from R & D to commercial supply.
Quality Strategy:
PDS advises on quality strategy for new products in the EU and USA, and can provide development and packaging strategies to optimise the characteristics of the product. This is in terms of formulation, presentation, packaging and manufacturing economics.
Quality Management Systems:
PDS can develop new quality management systems, specified to the structure and operation of the client. This is aligned with the needs of GMP, ISO 9000 and other relevant quality systems concepts.
Contractor Management:
PDS carries out routine contractor GMP reviews and in-depth audits for specific projects covering facilities, quality systems, manufacturing, packaging and analytical operations. This is both for small molecules and for biotechnology products.
Regulatory Inspections:
PDS assists companies to gain regulatory approval by reviewing the manufacturing processes and the submitted data, GMP review of the manufacturing facilities and quality management systems. PDS works with in-house QA experts to optimise the presentation of the facility and systems to the investigator, prepares response documents or appeals, and appears at oral hearings on behalf of the applicant.
Qualified Person:
PDS can provide a contract QP service to companies manufacturing or supplying both commercial and investigational medicinal products. Regulatory, manufacturing, packaging and labelling advice for clinical trial supplies can also be provided.
Overview:
PDS assists companies that are placing work at CROs for pharmaceutical development from early stage development to phase 3 and beyond. This involves CRO search and selection and includes analytical method development, compliance audits, clinical trial material manufacturing, packaging and labelling, quality management and QP release for clinical trials, technology transfer, new product introduction and project management.
Experience:
PDS has contracted entire chemistry, pharmacy and analytical programmes for the flovatriptan NDA. Contractors for chemical, analytical and pharmaceutical development were identified, evaluated and selected for a portfolio of six compounds. One major project involved relocating the manufacturing from one site to another for a multi-national pharmaceutical company.
Strategy:
PDS prepares a short-list of contractors with the requisite skills, reviews their facilities to ensure competence and prepares costings based on accurately-defined requirements. PDS commissions and manages contractors through every step of the process.
Training:
PDS offers in-house training in CRO selection and management including recommending SOP's, as well as systems to be put in place to limit the liabilities to ensure value for money.
Contact:
| Michael Gamlen | Managing Director, Technical |
PharmaTraining Services provides highly targetted training using experienced industry experts. We teach courses which are highly relevant but rarely covered by the other training providers. These include preformulation studies, tablet formulation development, Project Team skills, and the application of experimental design in product and analytical method development.
Contact:
| Michael Gamlen | Managing Director, Technical |
| Michael Gamlen | Managing Director, Technical |
New Pharmaceutical Training Service launched (24 May 2006)
Pharmaceutical Development Services Ltd and Pharmaterials Ltd launch PharmaTraining Services
PDS expands by appointing a Quality Management Consultant (2 Aug 2005)
PDS announces an expansion of its services by the appointment of a Quality Management consultant
PDS to offer a Pharmacovigilance service (19 May 2005)
PDS offers pharmacovigilance to meet the new requirements of the MHRA
Purchase of Tudor Health Care (1 Feb 2005)
PDS completes the purchase of the assets and goodwill of Tudor Health Care
PDS to purchase Tudor Health Care (21 Dec 2004)
PDS Ltd is in the final stages of purchasing the assets and goodwill of Tudor Health Care Ltd. The completion of the purchase is expected by the end of December 2004
Introduction:
Pharmaceutical Development Services (PDS) provides a consultancy and regulatgory services for pharmaceutical and biopharmaceutical products. We advise on drug development and production strategy including paediatric product development and medical devices. This includes the development, supply and regulatory control of new and existing pharmaceutical products. PDS was formed in 2000 and now boasts a staff of 10. PDS also works with a network of consultants who can provide specialist technical knowledge when required for a particular project. PDS can supply 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
Clients:
The clients of PDS range from small start- up biotechnology companies to large multi-national pharmaceutical companies. An increasing number of clients are located overseas.
Contractor Management:
PDS assists 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. PDS also advises on CRO issues and how to avoid the pitfalls on contracting out technical work.
Technology Transfer:
PDS audits laboratories and manufacturing facilities, including contractors for clients. 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.
Technical Development:
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.
Regulatory Affairs:
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.
Expert Witness:
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.
Training:
We provide expert in-house and public training courses through our sister business PharmaTraining Services (www.pharmatrainingservices.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
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