Excelya Expands Regulatory Affairs Services into Poland
Author:Maria (Marilina) Mastrogianni ,Medical Data Officer Published on: 24/03/2026
Estimated Reading Time: 6 min
Regularity Affair department
Introduction
Excelya is expanding regulatory affairs in Poland to help pharmaceutical companies benefit from flexible local execution backed by more than 20 years of European experience. 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.
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.
Regulatory Affairs
A proven regulatory platform now in Poland
20+
Years Active
100+
Clients
30–40
Projects / yr
1999
Founded
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.
Excelya’s expansion into Poland supports a broad portfolio of pharmaceutical regulatory services tailored to evolving client needs.
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Marketing authorisations, lifecycle support, and eCTD publishing
Our team supports marketing authorisation activities through national, DCP, and MRP procedures, including documentation for national phases. 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.
02
Quality translations, promotional review, and regulatory intelligence
Excelya provides quality translations for regulatory and product documents, review of promotional materials and artworks, and support in regulatory intelligence, training, and resourcing. These services help clients maintain compliance, stay current 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.
Regulatory Services · Poland
How Excelya delivers pharmaceutical regulatory services with local precision
Excelya’s model is built around clarity, continuity, and execution. Our teams combine technical expertise with a strong client-oriented mindset, delivering pharmaceutical regulatory services that are both dependable and adaptable.
01
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.
02
Integrated Local Compliance
In Poland, this includes national phases of DCP and MRP procedures, management of Module 1 documentation, adaptation of SmPC and patient information leaflets, and close attention to local procedural requirements.
Excelya integrates these elements from the start, helping clients reduce complexity, maintain quality, and move forward with confidence.
Frequently Asked Questions
What does Excelya’s expansion into Poland mean for clients?
It means clients can access local regulatory execution in Poland through a partner with more than 20 years of European experience and a proven coordination model across multiple EU markets.
What services does Excelya provide in Poland?
Excelya supports marketing authorisations, lifecycle management, eCTD publishing, quality translations, promotional material review, regulatory intelligence, training, 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.
Does Excelya support other regulated product categories?
Yes. In Greece and Cyprus, Excelya also supports medical devices, FSMPs, and food supplements, with ad hoc support across Malta, Austria, Romania, Portugal, and the Netherlands, our team has built a strong track record across European markets.
