Regulatory Affairs

Pharmaceutical Development Services - Pharmaceutical, Regulatory and Medical Device Consultancy

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 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.

CRO selection and CRO management issues

PDS consultants assist companies in the placing of work with CROs from the preclinical stage to phase three. 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.

Contract QP service

PDS' 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.

Medical devices

PDS provides both regulatory and technical assistance to medical device manufacturers. From pre-CE marking assistance and device classification through to vigilance support, PDS can advise clients on a wide variety of medical device issues.

PDS can assist with technical file preparation and maintenance and provide advice on labels, compliance, claims and instructions as well as arrange translations. In addition, the experienced team at PDS can prepare and submit documentation for clinical investigations or studies. For vigilance matters, PDS will advise, assist and submit adverse incident reports as required to the relevant competent authorities on behalf of clients. For device manufacturers outside of the EU, PDS can act as the authorised representative, maintaining a watching brief on all matters of concern to the client, including relevant regulatory updates.

Launching 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.

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 biotechnology compounds, PDS also has expertise with herbal medicines, nutraceuticals, cosmetics and medical devices.

Advice and guidance on legal disputes and due diligence

PDS 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. Michael Gamlen has extensive experience as a pharmaceutical expert witness. PDS have performed due diligence on product and portfolio purchases for a number of multinational companies.

Pharmaceutical training

PDS provides expert in-house and public training courses through their sister business PharmaTraining Services. See the website for their current training services.


BioCity Nottingham
Pennyfoot Street
Nottingham NG1 1GF

Tel: +44 (0) 115 912 4277
Fax: +44 (0) 115 912 4278