GMP Compliance Consulting Across Ireland, the UK, the EU and the US

Pharmalliance Consulting provides GMP compliance consulting across Ireland, the UK, the EU and the US. We help pharmaceutical, sterile, non-sterile, OSD, ATMP and cosmetic manufacturers meet the expectations of the HPRA, MHRA, EMA and FDA, from contamination control and validation to audits, remediation, training and regulatory readiness. Wherever your site or your target market sits, we work to the standard the relevant regulator applies.

GMP compliance consulting in Ireland

For manufacturers in Ireland, we support HPRA and EU GMP compliance across sterile and non-sterile operations, including contamination control strategy, EU GMP Annex 1 alignment, validation, and inspection readiness. Our team works on the ground with Irish sites preparing for or recovering from regulatory inspection.

GMP compliance consulting in the UK

In the UK we support MHRA GMP compliance and inspection readiness. Following the UK's divergence from some EU requirements, we help sites navigate both frameworks, maintain contamination control, and keep quality systems audit-ready for MHRA inspection.

GMP compliance consulting across the EU

Across the EU we work to EU GMP and EMA expectations, with particular depth in EU GMP Annex 1 for sterile products and the documented Contamination Control Strategy it requires. We support multi-site organisations harmonising quality systems across member states.

GMP compliance consulting in the US

For the US market we support FDA cGMP compliance, from responding to a Form 483 or Warning Letter to remediation and data integrity. We help sites, including 503B outsourcing facilities and API manufacturers, build the evidence of control FDA inspectors expect.

One standard, every region

What connects our work across Ireland, the UK, the EU and the US is a risk-based approach: controls tied to assessed risks, with evidence that they work. That is the standard regulators everywhere are converging on, and it is how we help sites move from documenting compliance to demonstrating control.

Frequently asked questions

Which regions does Pharmalliance work in?

Pharmalliance provides GMP compliance consulting in Ireland, the UK, the EU and the US, working to HPRA, MHRA, EMA and FDA expectations.

Do you support both EU and FDA GMP requirements?

Yes. We support EU GMP and EMA expectations, MHRA requirements in the UK, and FDA cGMP in the US, including sites that must satisfy more than one regulator.

What types of manufacturer do you work with?

Sterile, non-sterile, OSD, API, ATMP and cosmetic manufacturers, from single sites to multi-site global organisations.

About the author

Kieran Falvey is Founder and Managing Director of Pharmalliance Consulting Ltd and the creator of Contamination Control by Design (CCbD). He has more than 20 years designing, building and running pharmaceutical facilities worldwide, across FDA, EMA, TGA, PIC/S and Indian FDA (CDSCO) jurisdictions. Global expert in cGMP Compliance, Remediation and Contamination Control, helping Sterile, Non-Sterile, ATMP and Cosmetic companies navigate cGMP compliance issues.

About Pharmalliance Consulting

Pharmalliance Consulting is a GMP compliance consultancy serving pharmaceutical, sterile, non-sterile, OSD, ATMP and cosmetic manufacturers in Ireland, the UK, the EU and the US. It helps sites identify and remediate GMP risks across facilities, quality systems and contamination control, aligned with HPRA, MHRA, EMA and FDA expectations, turning findings into defensible, inspection-ready practice.

Need GMP compliance support in Ireland, the UK, the EU or the US? Explore our services, or contact the team to discuss your site.