Over two decades ago, we identified a series of gaps in the provision of services to the healthcare industry related to medical 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.

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 medical quality assurance 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.


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.


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


Ahead of the curve

Woodley BioReg 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.

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