Qualified experts

Industry and regulatory agency-experienced consultants to advise and guide your product development.

Find Out More

Qualified experts

Industry and regulatory agency-experienced consultants to advise and guide your product development.

Find Out More

Advice and guidance that you can trust, no matter the complexity of your project or product.

We only work with the very best time-served consultants; those with many years of industry or agency experience. We offer the highest quality technical knowledge at every stage — even on the most complex and niche projects — and are able to help you develop regulatory and quality strategies that ensure your success.

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regulatory affairs consultancy

We don’t just say, we do – Woodley BioReg holds a GMP licence from the UK’s MHRA. We don’t just say, we do – Woodley BioReg holds a GMP licence from the UK’s MHRA. 

We don’t just say, we do – Woodley BioReg holds a GMP licence from the UK’s MHRA. We don’t just say, we do – Woodley BioReg holds a GMP licence from the UK’s MHRA. 

case studies

We solve complexity

01

Guiding our client to develop and successfully register a third-generation vaccine

Read case study
02

Strategic use of a comparability protocol to bridge an intercontinental technology transfer using bio / analytical data and avoid bridging clinical studies

Read case study
03

Successful scientific advice to accelerate the development and registration of a biological product / biosimilar

Read case study
04

Developing and implementing quality systems to enable clients to be GMP certified

Coming soon
05

Review of medical device technical files and transition from MDD to MDR

Coming soon
06

Approved Dossier compliance and conformance review to address registration drift and avoid regulatory action

Coming soon
our expertise

We unlock
your potential

01

Pharmaceutical

From defining the Target Product Profile (TPP) through the preclinical / nonclinical stage, clinical development, right through to licence submission and maintenance, we can support you in developing effective regulatory and quality strategies to bring your product to market on time, and within budget.
02

Biopharmaceuticals

Our expert biopharmaceutical consultants specialise in the development and registration of complex biologics and biosimilars. With our finger on the pulse of this cutting-edge industry, we can help you navigate the complex landscape of regulatory approval for biopharmaceuticals.
03

Devices and Diagnostics

Woodley BioReg’s medical device and IVD specialists have been instrumental in the development of regulations, and can guide you through the changing legislative environment globally, as regulators look to keep up with the pace of innovation in this sector — enabling us to provide real value through strategy and delivery, for any type of product.
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we push the boundaries

Why us?

No matter how much or how little support you need, whether that’s flexible resourcing from the preclinical / nonclinical stage right through to Product Licence or certification maintenance, or if you just need light help at any step in between, you can be confident that Woodley BioReg will be there.

Expert industry professionals

With extensive experience and a successful track record in all aspects of regulatory affairs.

Regulatory and quality at our core

Consultants that are up to speed on the constantly shifting regulatory and quality landscape.

Global reach

Offices in the UK, Italy, USA and China, and partner groups in South Korea, and Poland.

Extensive industry knowledge

No project is too complex — our consultants will be able to offer advice and support.

Flexible resourcing

From “man in the plant” services to an extra pair of helping hands on a project, we’re here.

Best-in-class scientific advice

In regulatory affairs, clinical/nonclinical, and project management at all stages of product development.

Expert industry professionals

With extensive experience and a successful track record in all aspects of regulatory affairs.

Regulatory and quality at our core

Consultants that are up to speed on the constantly shifting regulatory and quality landscape.

Global reach

Offices in the UK, Italy, USA and China, and partner groups in South Korea, and Poland.

Extensive industry knowledge

No project is too complex — our consultants will be able to offer advice and support.

Flexible resourcing

From “man in the plant” services to an extra pair of helping hands on a project, we’re here.

Best-in-class scientific advice

In regulatory affairs, clinical/nonclinical, and project management at all stages of product development.

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