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Thought Leadership

Agency Meetings

Overview The long and costly development process for the development of new pharmaceuticals places huge commercial pressures on companies to secure Marketing Authorisations in...

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Thought Leadership

Analytical Development

Overview Pharmaceutical and healthcare products require detailed analysis — chemically, biochemically, and preclinical assessments — as part of the licence submission package to assure...

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Thought Leadership

Audits

Overview Audits are a critical pillar for the assurance of quality standards and should be designed to challenge pharmaceutical manufacturers and their related suppliers...

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Thought Leadership

Change Control Process

Overview Change Control is part of a company’s GMP Quality Management System (QMS) and ensures that the validation of the manufacture, testing, and release of healthcare...

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Thought Leadership

Clinical trial

A new drug registration must be approved for use by the regulatory and ethics committee before clinical trials are conducted. Studies are conducted in strict accordance...

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Thought Leadership

Development of Validation Master Plans (VMPs)

Overview Validation Master Plans (VMPs) are an integral part of the documentation required for process development and validation. Validation documents are used to systematically and accurately...

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Thought Leadership

Drug or Device Discovery

What is drug discovery? The pharmaceutical industry includes products borne out of drug discovery programmes, extensions to existing product lines, longstanding brand lines and...

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Thought Leadership

eCTD Publishing

All regulatory submissions are made in Non-eCTD electronic Submissions (NeeS) or electronic Common Technical Document (eCTD) format. eCTD format submissions have been mandatory in...

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Thought Leadership

Flexible Resourcing

Woodley BioReg has been resourcing projects for over 20 years, providing specialist regulatory, quality, and project management consulting services to the increasingly competitive and...

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Thought Leadership

GMP Accreditation

Overview Current Good Manufacturing Practice (cGMP) is the rigorous system and process that is legally required for the manufacture of all pharmaceutical products, including...

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Thought Leadership

Import Services

The European Boards of Health (BOH) seek to ensure that any licensed medicinal products brought into the EU by non-EU manufacturers meet EU law...

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Thought Leadership

License Variations

Overview Licence variations record the changes in methods of manufacture and testing that deviate from the originally approved methods and procedures. This approval can...

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Thought Leadership

Method Scouting

What is method scouting? Method scouting is the term used to describe the assessment of potential test methods during the early stages of product...

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Thought Leadership

New Product Registrations

Overview All new products are required to be registered by regulatory agencies and boards of health before it can be supplied for use. Similarly,...

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Thought Leadership

NTA to CTD

Overview The Common Technical Document (CTD) replaced the Notice to Applicants (NtA) for the submission of licence applications, becoming mandatory in Europe in 2006....

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Thought Leadership

Pharmacovigilance xEVMPD/QPPV

Overview All Marketing Authorisation Holders (MAHs) for any medicinal product authorised or registered within the EU and UK must submit information relating to the...

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Thought Leadership

Process Development & Validation

Process Overview Pharmaceutical companies typically manufacture at laboratory bench and pilot-scale for preliminary preclinical and toxicology studies and on occasion for phase I clinical trials. As more...

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Thought Leadership

Product License Maintenance

Product license maintenance overview Following approval, MAHs must ensure that Product Licence maintenance measures are implemented to ensure that the licence granted to the...

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Thought Leadership

Product Licensure

Product licensure overview Pharmaceutical products must be licensed prior to the commercial supply. This can be in the form of a Product Licence (PL)...

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Thought Leadership

Project Management

Overview Successful programme and project management of biopharmaceutical,  pharmaceutical, healthcare, over-the-counter (OTC), and medical device products requires a unique blend of technical, scientific, regulatory, and quality skills to ensure...

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Thought Leadership

Quality Management Systems

Overview Quality management systems (QMS) form the backbone of any commercial pharmaceutical or healthcare product. QMS comprises quality assurance (QA) and quality control (QC),...

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Whitepapers

Whitepaper: The impact of Brexit on the UK life sciences and pharmaceutical sector

The United Kingdom ceased to be a member state of the European Union on 31st January 2020, with the Brexit transition period ending on...

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