Frequently asked questions

McCulloch Regulatory Compliance (“MRC”) is an independent regulatory compliance advisory. It advises organisations in regulated industries on regulatory strategy, audits and inspections, clinical trials and pharmacovigilance, data protection and privacy, artificial intelligence, and product compliance, across the EU, UK, US and beyond.

MRC works across life sciences, technology and artificial intelligence, food and cosmetics, and financial institutions, and with any organisation subject to regulatory obligations in those fields.

No. MRC provides regulatory compliance advisory services. It is not a law firm and does not practise law. Nothing it provides constitutes legal advice, and a professional relationship is formed only under a signed engagement agreement.

Yes. MRC advises organisations established outside the United Kingdom and the Union, including in the United States and Asia-Pacific, on meeting their UK and EU regulatory obligations.

The practice is led by a Certified Information Privacy Professional/Europe (CIPP/E) and ISO 13485 Lead Auditor, with direct working experience of audits, inspections, and regulatory submissions.

Client documents are held in Microsoft 365 and SharePoint and accessed through scoped, application-level credentials. The measures in place are set out in the Trust Center.

An engagement begins with an initial discussion of the organisation's circumstances and requirements, followed by a scoped proposal and a signed engagement agreement.

Yes. MRC acts as an outsourced Data Protection Officer under the UK GDPR and EU GDPR, with a specialism in clinical trials, and is establishing EU representation for clinical trial sponsors and controllers established outside the Union.