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Pharmaceutical Development Services

Pharmaceutical, Regulatory and Medical Device Consultancy

January 31, 2011

Pharmaceutical Consultancy PDS Expands to Include a Strategic Alliance with Compliance Control Ltd. and a Work Team to Include CMC Dossier Rectification Expert Sean McCrossen

Pharmaceutical Development Services Limited (PDS) is delighted to announce a new strategic alliance with compliance control, and the addition of...
pharmacuetical business review
November 8, 2010

The Compressibility Company Ltd Introduces a Unique Tablet Press at the AAPS

Michael Gamlen, managing director, Pharmaceutical Development Services will be introducing the PCT1 - a new small scale, computer controlled tablet...
pharmacuetical business review


Pharmaceutical Development Services

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

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Active Substance (API) Sourcing

Pharmaceutical Development Services can assist you in evaluating and setting up your drug sourcing strategy.

PDS' expert consultants in the identification and evaluation of possible sources for active pharmaceutical ingredients will lead you through the minefield of finding compliant, low cost sources of drug substances. With a wealth of experience in China and India, PDS can find companies who offer good value as well as reliable and compliant sourcing of…

Building Design and Validation

Consultant advice on the refurbishment and design of pharmaceutical facilities.

Designing a facility to comply with the complex requirements of GMP and cGMP is a highly skilled business; mistakes can cost millions to rectify and result in regulatory failure. PDS' expert building consultants have designed facilities all over the world for a range of clients including multinational pharmaceutical companies. PDS can assist you with design,…

Contractor Management

PDS offers a full contractor management programme, ensuring smooth progress.

PDS assists companies that are placing work at CROs for pharmaceutical development from early stage development to phase three 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…

Herbal Product Registration

PDS compiles and submits herbal marketing authorisations.

PDS can assist you at all stages of generating and submitting herbal licence applications including: Preclinical Clinical Manufacturing Regulatory submission PDS' regulatory consultants have many years of experience of herbal licence product compilation.

Medical Device Registration

PDS generates submissions for medical devices of all classes.

Class I devices Including both sterile,non-sterile and measuring function, PDS can: Provide general pre-CE marking assistance by reviewing your product, determining its device classification and route to conformance Assist with technical file preparation and maintenance Provide advice on labels, arrange translations and check compliance, claims and instructions Help ensure QA compliance including operating procedure advice…

Pharmaceutical Development

Development of solid-dose formulations, project management, production strategy and due diligence.

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…

PharmaTraining Services

Providing expert specialist training in key development areas.

PharmaTraining Services provides a unique suite of friendly, but highly targeted easy-to-learn courses for busy pharma and biotech professionals. Delivered by industry experts, the courses are designed to ensure attendees are aware of all the latest developments in their industry helping to position themselves ahead of the game. The courses are not only highly relevant…

Quality and Compliance

Quality management and new product introduction, including technology transfer and industrialisation in Europe and the US; QP services.

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…

Technical Due Diligence

Due diligence associated with product or licence purchase.

PDS offer a complete technical due diligence service covering the preclinical, clinical, CMC (manufacturing) and regulatory aspects of any transaction. PDS consultants work quickly to respond to tight deadlines, and provide you with an expert opinion on which you can base your future strategy with confidence. PDS identify dogs and provide you with relevant warnings.
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