— Case Study —

Successfully Maintaining an OTC Portfolio Across Multiple European Markets

Introduction

Pharmaceutical companies seeking to commercialise and maintain products across multiple European markets often face significant operational and regulatory challenges, particularly when they lack an established in-region infrastructure. This case study highlights how regenold supported a global pharmaceutical organisation with the transfer and long-term management of a large over-the-counter (OTC) medicine portfolio across Europe. Through a fully integrated Marketing Authorisation Holder (MAH) model combined with regulatory, pharmacovigilance, quality, and compliance services, we enabled a seamless portfolio transition while establishing the foundations for sustainable future growth.

The Challenge

The client required support to deliver a complex, multi-country programme involving:

The transfer of 20+ OTC marketing authorisations across multiple European markets into a new MAH entity
Establishment of a fully compliant operational infrastructure, including wholesale distribution authorisation and compliance oversight
Managing country-specific regulatory and legal requirements across diverse jurisdictions
Ensuring continuity of pharmacovigilance, quality, promotional review and medical information services throughout the transition
Addressing gaps in regulatory documentation and dossier quality
Maintaining strong governance and oversight, while enabling efficient in-country delivery

This programme required close coordination across multiple disciplines, teams, and geographies, with minimal disruption to ongoing commercial and compliance activities.

Our Comprehensive Approach

regenold delivered an integrated, cross-functional solution, combining strategic oversight with hands-on delivery:

1. Wholesale Distribution & GDP Compliance

Supported the set-up of the client’s Wholesale Dealer’s Authorisation (WDA)
Implemented Good Distribution Practice (GDP) frameworks, ensuring regulatory compliance
Provided practical guidance on establishing operational processes and responsibilities with the client team, whilst fulfilling Responsible Person/deputy Responsible Person roles

2. MAH Set-Up & Licence Transfer

Led the transfer of over 20 OTC licences into our MAH entity across Europe
Supported the transfer of marketing authorisations and associated regulatory data, ensuring continuity and compliance
Established governance frameworks to enable effective MAH operations and client oversight

3. Local Market Regulatory Support

Delivered in-country expertise to meet local legislative requirements
Ensured compliance with country-specific regulatory obligations
Coordinated activities centrally to maintain alignment across markets

4. Dossier Remediation & Regulatory Readiness

Performed dossier remediation activities, addressing gaps and inconsistencies across the portfolio
Strengthened regulatory documentation to support ongoing lifecycle management
Enabled improved readiness for variations, renewals, and inspections

5. Pharmacovigilance, Quality & Medical Information

Provided immediate in-country support across key operational areas:

Pharmacovigilance, including EU and local Qualified Person for Pharmacovigilance roles
Quality event management
Medical information services, including local responsible person roles

Ensured uninterrupted delivery of critical compliance and patient safety activities

6. Promotional & Commercial Compliance Support

Supported promotional campaign and material review activities
Ensured alignment with local regulatory requirements
Enabled a risk-based review approach, balancing compliance with efficiency

Benefits

Successful transfer and operationalisation of a multi-market OTC portfolio in an MAH structure that enabled client to continue supply of medicines without full in-region operational teams
Establishment of a fully compliant GDP and wholesale distribution framework
Regulatory documentation quality issues addressed and resolved against a risk-based timescale
Seamless continuation of pharmacovigilance, quality, and medical information services in country
Strengthened governance, visibility, and control across multiple countries and functions
Creation of a scalable platform to support future lifecycle management and portfolio growth

Conclusion

This programme demonstrates regenold’s ability to deliver end-to-end pharmaceutical support across regulatory, quality, and safety domains. By combining strategic expertise with local execution, regenold enabled the successful transition to a new, fully serviced MAH governance structure while ensuring compliance, continuity, and long-term scalability.