Qualified experts

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

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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.

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

04

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

05

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

06

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

our expertise

We unlock
your potential

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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.

Let’s discuss your project

What can we help you achieve?

Talk to us