regenold UK

Regulatory Affairs, Quality, and Pharmacovigilance for the UK Market.

Our team of highly experienced UK experts are ready to guide you through the specific complexities of the UK pharmaceutical and medtech environment. We have longstanding connections within and understanding of the UK environment, in particular with MHRA. This enables us to guide our clients seamlessly through MHRA interactions and to provide regulatory operational support. We also provide named compliance roles on our own licences, and run pharmacovigilance and medical information services for UK marketing authorisation holders. Our offices are in Barnstaple and Nottingham. For Ireland, see regenold Ireland.

regenold UK
— What We Do Locally —

UK Services

Our specialised UK team delivers local regulatory operations, compliance roles, and safety services. For the full methodology, workstreams, and deliverables behind each service, see the central regenold service pages.

Regulatory Affairs →

MHRA submissions, scientific advice, clinical trial applications, marketing authorisations, PIPs, Rx-to-OTC programmes, and lifecycle management.

Quality & Compliance →

We provide responsible persons and Responsible Person for Import to be named on client Wholesale Distribution Authorisations. GDP operations, inspection preparation, and post inspection remediation.

Pharmacovigilance →

UK QPPV and National Contact Person services. PV system operation, case management, signal detection, aggregate reporting, clinical trial safety, UK PSMF, Local Literature and UK Risk Management Plans.

Medical Information →

Outsourced MI for UK MAHs. Enquiry handling, standard response libraries, adverse event triage, and ABPI Code compliance.

Product Information & Promotional Compliance →

Copy approval, artwork review, labelling management, and ABPI Code certification for promotional and non-promotional materials.

Marketing Authorisation Holder & Named Compliance Roles →

RP, RPi, QPPV, and NCP. We hold Manufacturing authorisations, employ the named persons, and take responsibility for the compliance obligations.
— Why regenold UK —

What Distinguishes Our UK Practice

Specialised knowledge and experience of the UK pharmaceutical environment including MHRA. Our team of experts work with the MHRA on a daily basis. We know the UK procedures, the timelines, the expectations and nuances from hands on experience and not from reading guidance at a distance.

We take accountability, meaning when your product is on our licence, it is our responsibility. We don’t outsource compliance roles to third parties – instead we have our own QPs, RPs, QPPVs, and NCPs.

We are part of regenold who was founded in 1994. The UK team works closely with colleagues in Germany, Ireland, and Portugal and draws on central expertise in CMC, clinical development, device regulation, and market access across 90+ countries via regulanet®.

We are Post-Brexit specialists, managing the ever-growing UK-EU regulatory divergence daily: evolving UK regulatory frameworks are driving specific requirements in multiple areas including submissions, product information, PV obligations and advertising codes. If you need to achieve and maintain authorisations in both the UK and the EU, we handle the UK side and coordinate with our Ireland and EU teams for the rest.

We are deeply integrated with our Ireland office. For products marketed in both the UK and Ireland, we coordinate MHRA and HPRA submissions, maintain separate product information, and manage divergent requirements without duplication. See regenold Ireland for our Ireland services.

Need Support in the UK?

Tell us about your product and your regulatory situation, and we will outline how we can help.

Speak with an Expert
— About Us —

Part of regenold

regenold UK is part of regenold, a regulatory affairs and development services company founded in 1994 and headquartered in Germany. regenold operates through offices in the UK, Portugal, Ireland, Switzerland, and Germany, enabling seamless cross-border collaboration in client projects.