Excelya Expands Regulatory Affairs in Poland

Author:Regulatory Affairs Department
Published on: 01/04/2026

Estimated Reading Time: 7 min

Regulatory Affairs Department

Introduction

Excelya is bringing its Regulatory Affairs services for human pharmaceutical products to Poland, offering pharmaceutical companies flexible local execution backed by more than 20 years of regulatory experience in Greece, Cyprus, and other EU markets. As the largest pharmaceutical market in Central and Eastern Europe, Poland represents a strategic opportunity for companies seeking reliable pharmaceutical regulatory services with both local precision and broader EU alignment. With this new step, Excelya strengthens its European footprint while continuing to offer tailored regulatory support, strong project coordination, and the consistency clients need to navigate evolving market and compliance requirements with confidence.

Jump to section

1Regulatory affairs Poland

2Why trust Excelya

3Our Tailored Services

4Local Execution

5Looking Forward

6Regularity Support FAQ

Regulatory affairs Poland

Why Poland Matters in Today’s European Regulatory Landscape

Poland has become an increasingly important market for pharmaceutical companies operating across Europe. As the largest pharmaceutical market in Central and Eastern Europe and the fifth-largest drug market in the EU by value, it represents a strategic priority for companies that need to align local execution with wider European objectives.

A Market Defined by More Than Scale

Its importance goes beyond scale alone. Poland combines a strong domestic pharmaceutical sector with a competitive environment shaped by innovative, generic, and biosimilar activity. This means regulatory quality, timing, and coordination can have a direct impact on lifecycle planning, compliance, and market continuity.

More Than Adding a New Geography

That is why regulatory affairs in Poland is more than simply adding a new geography. It requires a clear understanding of local requirements, close coordination of submissions and lifecycle activities, and the ability to keep national obligations aligned with broader EU strategy.

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In a market where regulatory precision shapes commercial outcomes, Poland demands the same strategic attention as any major European market.

Why trust Excelya

A proven regulatory platform now in Poland

Years Active

20+

Clients

100+

Projects / yr

30–40

With more than 20 years of continuous activity in Greece and Cyprus, and ad hoc support across Malta, Austria, Romania, Portugal, and the Netherlands, our team has built a strong track record across European markets.

This experience includes marketing authorisations, lifecycle management, labelling support, and national compliance coordination across EU member states.

That experience shapes the way we approach regulatory affairs in Poland today, bringing mature processes, reliable coordination, and the practical understanding clients need from a trusted partner.

Lifecycle Management
Marketing Authorisations

Pharmaceutical products and capsules displayed to represent regulatory affairs in Poland

Our Tailored Services

The services clients can access through Excelya

Excelya’s expansion into Poland supports a broad portfolio of pharmaceutical regulatory services tailored to evolving client needs.

Service Area

Marketing authorisations, lifecycle support, and eCTD publishing

With our expansion into Poland, Excelya’s Regulatory Affairs department now supports marketing authorisation activities through national, DCP, and MRP procedures. We also provide lifecycle support for variations, renewals, labelling updates, and dossier maintenance, alongside eCTD publishing services that help clients manage submissions efficiently across markets.

Service Area

Quality translations, promotional review, and regulatory intelligence

Excelya provides quality translations for regulatory and product informations, review of promotional materials and artworks, and support in regulatory intelligence, training, and resourcing. These services support clients maintain compliance, stay aligned with changing requirements, and scale expertise when project needs evolve.

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For Greece and Cyprus, we also support medical devices, FSMPs, and food supplements, reflecting the depth of regional expertise Excelya brings to every market it serves.

Local requirement, European standards

How Excelya delivers pharmaceutical regulatory services with local precision

Excelya’s model is built around clarity, continuity, and dedication. Our teams combine technical expertise with a strong client-oriented mindset, delivering pharmaceutical regulatory services that are both dependable and adaptable.

Single Point of Contact

Clients benefit from one dedicated contact throughout the project lifecycle. This improves continuity, reduces communication gaps, and gives teams clearer visibility on timelines and deliverables. Over time, this model builds product knowledge that supports recurring activities and helps resolve issues more efficiently.

Integrated Local Compliance

In Poland, this includes handling national-phase requirements for DCP and MRP procedures, managing Module 1 documentation, adapting SmPCs and patient information leaflets, ensuring close attention to local procedural requirements, and maintaining established collaboration with local authorities.

Excelya integrates these elements with deep experience, helping clients reduce complexity, maintain quality, and move forward with confidence.

Pharmaceutical vials on a production line highlighting regulatory operations in Poland

Looking Forward

A trusted regulatory partner for Poland and beyond

With regulatory affairs in Poland, clients gain more than local coverage. They gain a partner that combines national requirements with broader European alignment, helping ensure continuity across markets and reducing coordination gaps between regulatory, compliance, and operational teams. This gives clients flexible access to pharmaceutical regulatory services adapted to the realities of a highly regulated environment.

Excelya’s expansion into Poland reflects a clear ambition to remain a flexible, dependable, and high-value regulatory partner for clients across Europe. As our footprint grows, our commitment stays the same: to provide tailored support, strong coordination, and the level of professionalism complex regulatory environments demand. Learn more about our broader expertise through Excelya’s regulatory affairs page.

Frequently Asked Questions

What does Excelya’s expansion into Poland mean for clients?

It means clients can access local regulatory activities in Poland through a partner with more than 20 years of European experience and a proven coordination model across multiple EU markets.

What Regulatory Affairs services does Excelya provide in Poland?

Excelya supports marketing authorisations activities, lifecycle management, eCTD publishing, quality translations, promotional material and artwork review, regulatory intelligence, trainings, and resourcing

Why is local regulatory support important in Poland?

Local support helps companies manage national requirements efficiently while keeping activities aligned with broader EU regulatory strategy. It also supports smoother handling of national-phase procedures and local compliance needs.

Can Excelya support both long-term and project-based needs?

Yes. Excelya supports ongoing regulatory activities as well as ad hoc project-based work, allowing clients to scale support according to changing priorities.