About Woodley BioReg
Around 2000 we identified a series of gaps in the pharmaceutical industry. The regulatory affairs sector was undergoing significant change and companies required high quality, science-driven solutions, and pragmatic guidance to support and balance the high expectations of ICH, FDA and EMA (previously EMEA). This was compounded by the diverse range of biopharmaceuticals that were starting to enter the registration processes.
Two ex-FDA inspectors also “suggested” an industry need for specialist regulatory guidance for the development and registration of biological products, including vaccines in the USA and the EU, utilising the founding consultant’s key skill set.
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 compliant, well-regulated drugs.
Since 2000, 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 Poland, India and partner groups in South Korea and USA.
Today Woodley BioReg’s core services include:
• Regulatory Affairs Registrations Support
• Regulatory Affairs Resourcing
• Quality System support
• Project 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:
• Project and Programme Management
• Registration Strategy Development
• CTD and eCTD publishing for licence submissions globally
• Determination and remediation of Registration Drift
• Life-cycle management, licence maintenance and due diligence activities.
Underpinning this are Woodley BioReg’s founding principles 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.
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.