The Problem?

Around 2000 we identified a series of gaps in the pharmaceutical industry;

The pharmaceutical industry includes products borne out of drug discovery programmes, extensions to existing product lines, longstanding brand lines and generics, and prescription-only-medicines.

A major challenge for the pharmaceutical industry is the long and risky development process for new drugs; this is costly and can take over ten years from the laboratory to clinical trials. Typically, only around five out of 5,000 compounds that have been assessed at the pre-clinical stage will reach human clinical trials. Of these five, only one will eventually be approved by the regulatory authorities. The investment of time and cost in such processes places a significant strain on drug developers. Woodley BioReg provide early strategic advice in clinical, nonclinical, CMC/ manufacturing, and regulatory pathways to ensure clear routes and risk mitigation.

In addition to the regulatory and technical challenges, the founders had a personal interest, and recognition, that whilst drug development was an international industry, many in developing nations were receiving pharmaceutical products of lower quality, efficacy, and safety than those in the developed world.

This highlighted a fundamental need to support the international pharmaceutical industry to manufacture GMP compliant, well-regulated drugs.

The Process

Since inception, Woodley BioReg has grown consistently and is now headquartered in Huddersfield, Yorkshire and staffed with highly qualified and experienced industry professionals working on projects throughout the UK and internationally.

WBR has offices in China, Poland, India and USA, and partner groups in Italy and South Korea.

The Solution

Today Woodley BioReg’s core services include:

• Regulatory affairs registrations support
• Regulatory affairs resourcing
• GMP / quality system development and support
• Pharmaceutical project and programme management

This provides support to clients from product and clinical development, though product licensure, GMP compliance, to maintaining regulatory strategies post Marketing Authorisations and training.  

Woodley BioReg is keen to stay ahead of the curve and continues to offer solutions to a wide range of industry challenges. These include:

• Registration strategy development
• eCTD publishing for licence submissions globally
• Determination and remediation of registration drift
• Life cycle management, licence maintenance,
and due diligence activities.

Woodley BioReg’s founding principles are to supply high quality regulatory and quality advice underpinned by sound technical and scientific rationale.

This approach has been the bedrock of our success, and our honesty, integrity, and attention to detail has been repeatedly recognised by our clients, peers and boards of health.

The Result

Woodley BioReg has worked with a wide variety of clients, from some of the world’s largest pharmaceutical companies to start-up biotech organisations. Early stage products have benefited from increased speed to market, through sound regulatory advice and guidance, whilst larger corporate clients have been able to outsource elements of their projects providing significant cost savings.

Each client has a dedicated project team to ensure work is managed and driven to deliver ahead of time, often below budget. Our consulting professionals integrate with the client company to ensure they deliver as part of the team, providing flexible support both onsite and remotely.


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