Pharmaceutical Development Services - Integrated Drug Development Consultancy

Pharmaceutical Development Services Ltd (PDS) provides a consultancy service for integrated drug development. This includes the development, manufacture and regulatory control of new and existing pharmaceutical products and active ingredients. The main areas of expertise are:

• Contractor selection and management
• New product introduction strategy
• Clinical trial manufacturing, packaging and labelling
• Validation, quality assurance and QP release
• Regulatory affairs
• Training and development

PDS also works with a network of consultants who can provide specialist technical knowledge when required for a particular project.

CRO MANAGEMENT

PDS assists companies in the placing of work with CROs from the preclinical stage to marketing. This involves CRO selection for particular projects depending on their skills, and PDS advises on CRO issues and how to avoid the pitfalls on contracting out technical work.

NEW PRODUCT INTRODUCTION

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 regulatory requirements and is marketed properly with the right amount of product in the right place at the right time.

CLINICAL TRIALS AND QUALITY STRATEGY

The area of clinical trials supply management is another important part of the work of PDS. This includes areas as diverse as inspection of manufacturing facilities, management of packaging, labelling and QP release. PDS can audit laboratories and manufacturing facilities to ensure compliance with the GMP requirements of the Clinical Trials Directive. We can also inspect contractors on behalf of clients. PDS can advise a client on the strategy to adopt to ensure quality assurance, and also undertakes pre-approval and other regulatory inspections.

REGULATORY AFFAIRS

PDS has an experienced regulatory affairs department. The work ranges from providing 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. PDS has experience of reformatting existing regulatory dossiers to comply with the Common Technical Document format that is now obligatory in all EU member states, including those in the ten EU accession countries. With the purchase of Tudor Health Care in January 2005, PDS now offers regulatory expertise in orphan drugs, herbal medicines, nutraceuticals, cosmetics and class 1 medical devices.

TRAINING AND DEVELOPMENT

PDS consultants regularly speak at conferences, and give seminars and presentations on courses run by the Centre for Professional Advancement and the Royal Pharmaceutical Society of Great Britain. PDS also gives presentations to companies in-house. These are often in the form of short training courses, which are tailored to the requirements of the client.

INTERIM MANAGEMENT

PDS is able to supply staff to clients on a contract basis for a particular project. For example, one of the consultants is working for a blue-chip pharmaceutical company abroad for three days a week. This is useful for a client who might require an extra member of staff for a particular project, but cannot justify taking on another member of staff on a permanent basis.

PDS always welcomes informal enquiries and the Business Development Manager, Julian Cooper, can be contacted at the address below: