About Us


Who we are

Providing solutions to problems.

Over two decades ago, we identified a series of gaps in the provision of services to the healthcare industry related to quality assurance and regulatory affairs. With the intention of bridging those gaps and providing pharmaceutical, biopharmaceutical, and device / diagnostic manufacturers with the skills, experience and resources that they need to succeed, Woodley BioReg was formed.R

Now, our teams of ex-regulator and ex-industry specialist consultants are at the forefront of the sector, relishing the challenge of complex and niche projects that other consultancies would be unable to support, while also providing great value in the “bread and butter” activities of the regulatory and quality world.

A global consultancy

With our head office in the UK, EU base in Italy and satellite offices in the US and China — as well as partners in South Korea and Poland — we’re a truly global consultancy that understands the intricacies of the regulations across borders worldwide.

And as the only regulatory consultancy in the UK to hold a GMP licence, issued by the MHRA, we don’t just say we’re able help you do the same, we evidence it every day through our licence maintenance activities.

A truly international consultancy

WBR has offices and partner groups in






South Korea






South Korea

What you need, when you need it

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.

The Process
The Solution

Who we help

Our core sectors include:

  • Pharmaceuticals
  • Biopharmaceuticals
  • Medical devices and In Vitro Diagnostics

But we also support clients working in:

  • Nutraceuticals
  • Over-the-counter medicines (OTCs)
  • API manufacture

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

  • Biologics / biosimilars development
  • Strategic regulatory advice to ensure fastest route to market
  • Determination and remediation of registration drift
  • Life cycle management, licence maintenance, and due diligence activities

Our 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.

Ahead Of The Curve
The Result

Where we are now

Each of our clients — varying from some of the world’s largest pharmaceutical companies to start-up biotech organisations — has access to a dedicated project team to ensure work is managed and driven to deliver ahead of time and often below budget.

Providing flexible support both onsite and remotely, we strive each day to provide only the best, up-to-date regulatory advice and guidance – resulting in early-stage products benefiting from increased speed to market, as well as established products remaining compliant in line with any changes in legislation.

Kind words from our clients



Excellent level of focussed service

They have provided an excellent level of focussed service and support to our regulatory and product conformance projects. Their services are competitively priced but uncompromising in their quality.

Associate Director, EU regulatory Affairs
Top 10 Pharmaceutical Company


Commitment and dedication

Shown commitment and dedication over and above what you would sometimes expect from permanent members of staff, and is well respected by the people he has worked with and for.

Senior Manager, Regulatory Conformance
Top 10 Pharmaceutical Company


Commitment and dedication

The effective way in which you took up the challenges of the assignment, together with your clear understanding of our business needs have played a key role in helping us achieve our targets.

AVP International Regulatory Affairs
Top 10 Pharmaceutical Company


Worked extremely hard

Approached tasks with enthusiasm and worked extremely hard to pull together these submissions.

Through it all, have been diligent, highly responsive, proactive, communicative, and as a bonus, extremely good natured.

Associate Director, EU Regulatory Affairs
Top 10 Pharmaceutical Company


Excellent consultant with vast experience

Excellent consultant with vast experience in both Regulatory and QA arenas: pragmatic scientist with high quality standards, he has resolved many issues.

Has been able to manage / coach personnel very efficiently. Finally, he knows the idiosyncrasy of the Company and the intricacies of products very well.

Successfully wrote module 3, submitted and approved with minimal request for further information.

Director, Regulatory Development
International Pharmaceutical Company

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