About the practice
An independent regulatory practice
McCulloch Regulatory Compliance is a focused, independent advisory practice. We work with organisations across regulated industries, from development-stage companies to established businesses, navigating the regulatory compliance obligations that apply to their products, operations, and data.
We work across the EU, UK, US, and other major markets, combining technical knowledge with practical regulatory experience. Clients come to us at every stage, from shaping a development programme to preparing for an inspection, responding to a safety issue, or meeting data protection obligations. The advice we provide is tailored to each client’s circumstances rather than templated.
The practice is intentionally lean. Clients work directly with experienced advisers who know the science and the regulatory framework around it, rather than through layers of account management.
Our approach
How we work
Anticipatory strategy
We define the regulatory pathway from the outset, so that development, manufacturing, and market-access decisions are made with the full requirements already in view.
Practical application
We advise on how regulations work in practice, how authorities interpret them, how inspectors apply them, and the steps organisations must take in response.
Across the lifecycle
Regulatory obligations change as a product matures. We work across the full lifecycle and stay involved as those obligations evolve.
Quality as a foundation
Quality principles inform all of our work, including the increasingly complex compliance landscape around AI and emerging technologies.
Privacy by design
We incorporate data protection requirements from the start of any project, not as an afterthought, treating GDPR obligations as part of the regulatory framework rather than separate from it.
Sectors
Who we work with
- Biotechnology
- Pharmaceuticals
- Medical devices
- In vitro diagnostics (IVD)
- Combination products
- Digital health & AI
- Food & cosmetics
Affiliations
Professional standing
Our advisers hold relevant professional qualifications, including ISO 13485 Lead Auditor and CIPP/E (IAPP) certification in European data protection. Full credentials and affiliations are listed on each person’s profile.
Meet the team →