Excelya Regulatory Affairs

Regulatory Affairs

Where strategy meets compliance, turning requirements into results.

Our Regulatory Affairs department ensures confident, accurate, and timely submissions, guiding your product from development to market access while maintaining full compliance throughout its lifecycle.

With more than 25 years of operation and 100+ clients, our team brings deep expertise across therapeutic areas, product categories, and regulatory pathways.

We deliver a wide range of regulatory affairs services, from dossier preparation and marketing authorisations to lifecycle maintenance, pricing, reimbursement, regulatory compliance, and legislation monitoring for pharmaceutical products. We also provide local regulatory support for medical devices, food supplements, and FSMPs in Greece and Cyprus.

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Regulatory Affairs in Numbers

At a Glance

25+ years

of continuous operation

100+ clients

served since 1999

30 to 40

projects per year

20+ years

with long term clients

350+ eCTD

submission packages since 2020

2 to 15+ years

RA team member experience

Operating Regions

Main Geographic Expertise

Greece

Cyprus

Poland

Operating Regions

Ad hoc Support

Netherlands

Portugal

Austria

Romania

Malta

Our Mission and Strong Points

Our Mission

Our mission is to secure marketing authorisation approval while ensuring products meet all legal and regulatory requirements. We work to maintain uninterrupted market availability and help avoid stockouts, while also providing the regulatory framework needed for successful commercial strategies. Across every stage, our team supports the entire post approval lifecycle with a focus on compliance, continuity, and long-term product success.

Regulatory Affairs Capabilities

Our Services

Marketing Authorisation Activities

For medicinal products:

Marketing Authorisation Applications (MAA) submissions for DCP, MRP, and National Procedures

Variations and Renewals submissions

Effective collaboration with Authorities and follow up of submissions, supporting timely conclusion of procedures

Submission and coordination of Transfers of Marketing Authorisations

High quality translations of Patient Information documents

Regulatory Compliance and Maintenance Activities

We ensure your medicinal product remains compliant and continuously available.

Review of artworks and packaging material

Review of promotional material

Local activities for Centralised Products

Consultancy services on local regulatory provisions and requirements

Actions related to product availability

Market Access for Greece and Cyprus

For medicinal products:

Pricing and reimbursement applications

National launch requirements

Monitoring of legislative changes

Coordination between MAH, distributor, and 3PL for marketing activities

eCTD Publishing and Technical Dossier Support

Preparation of eCTD sequences

Initial MAA, variations, renewals, transfers, and related submission types

Submission packages for EU countries

Regulatory Intelligence

Legislation monitoring

Preparation of summaries and updates per subject

Guidance on national requirements

Medical Devices, Food Supplements and FSMPs for Greece and Cyprus

Local registrations, including medical device registration where applicable

Translations

Labelling and artwork review

Claims review

Compliance with EU and local requirements

Market access activities

Training and Resourcing

Tailored regulatory training

On site placement of RA staff, full time or part time

Flexible support tailored to your operational needs

Regulatory Collaboration

Our Partnerships

Flexible Collaborations for Every Regulatory Requirement

Foreign pharma companies without local affiliates

Local companies with limited internal RA capabilities

Companies needing tailored RA support

Medical device, food supplement, and FSMP companies in Greece and Cyprus

Companies seeking long term or on demand RA partnerships

Case Study

See Our Regulatory Affairs Support in Action

Explore how Excelya delivered tailored Regulatory Affairs support, helping a client move forward with flexibility, expertise, and confidence.

Read the Case Study

Regulatory Affairs Partnership

Our Commitment

Your product deserves a confident, compliant, and seamless path to market.

We bring together flexibility, deep regulatory knowledge, excellent Authority relations, and a client centered approach, ensuring accurate submissions, efficient processes, and successful outcomes.

We are here to guide every step.

Get in touch

Looking for regulatory affairs support for your next submission, market access activity, or lifecycle maintenance needs?

Let us help you move forward with confidence.

Submit your request

Frequently Asked Questions

What regulatory affairs services does Excelya provide?

Excelya provides end to end regulatory affairs services for pharmaceutical products, medical devices, food supplements, and FSMPs. Our support covers marketing authorisation applications, variations, renewals, regulatory compliance, lifecycle maintenance, market access, eCTD publishing, regulatory intelligence, training, and tailored resourcing. We help companies manage regulatory requirements with accuracy, efficiency, and continuity.

How does Excelya support marketing authorisation applications?

Excelya supports Marketing Authorisation Applications for DCP, MRP, and National Procedures. Our regulatory affairs team manages submission preparation, authority follow up, variations, renewals, transfers of marketing authorisations, and high quality translations of patient information documents. This helps ensure accurate submissions and timely progress through regulatory procedures.

Can Excelya support regulatory affairs activities in Greece and Cyprus?

Yes. Excelya provides local regulatory affairs support in Greece and Cyprus, including market access activities, pricing and reimbursement applications, national launch requirements, legislative monitoring, local registrations, artwork and labelling review, and coordination between MAHs, distributors, and third party logistics providers. We also support medical devices, food supplements, and FSMPs in these markets.

What is included in Excelya’s regulatory compliance and lifecycle maintenance support?

Excelya helps companies keep products compliant and continuously available throughout their lifecycle. Our services include artwork and packaging review, promotional material review, local activities for centralised products, consultancy on local regulatory provisions, product availability actions, and post approval lifecycle support. This helps reduce compliance risk and supports uninterrupted market presence.

Who can benefit from Excelya’s regulatory affairs partnerships?

Excelya partners with foreign pharma companies without local affiliates, local companies with limited internal regulatory affairs capabilities, and organisations needing tailored or on demand RA support. We also support companies in the medical device, food supplement, and FSMP sectors, especially those looking for long term regulatory partnerships in Greece, Cyprus, and selected European markets.