What EU Market Entry Actually Requires
If you have brought a product to market in the US, China, or Japan, the EU process will look broadly familiar. What is less familiar may be everything that must be in place around the submission. The EU regulatory framework places substantial operational obligations on whoever holds the authorisation or certificate, and the infrastructure must be operational.
Pharmaceuticals
An EU-based MAH entity (or a partner acting as MAH). A Qualified Person for batch certification and release named on a Manufacturing and Import Authorisation. An EU-resident QPPV with 24/7 availability. A Responsible Person for wholesale distribution. Local PV contacts where required (e.g. Stufenplanbeauftragter in Germany). A local Scientific Service/Drug Information Officer where required. A Pharmacovigilance System Master File PSMF and registered safety database. A quality system aligned with EU GMP/GDP. All operational before the first commercial batch is released.
Paediatric Compliance for MAA Submission
In order to achieve validation of an MAA in the EU Centralised Procedure, a paediatric investigation plan (PIP) or a waiver must have been agreed with the European Paediatric Committee (PDCO). Gaining a PIP approval can take many months and without it, a Centralised submission will not be validated.
Medical devices
Legal Manufacturer with ISO 13485 QMS (or EC REP under MDR Article 11). PRRC. Technical documentation per MDR Annex II/III. Notified Body for Class IIa+. EUDAMED registration and UDI (mandatory from May 2026). Post-market surveillance in place for launch.
Clinical trials
EU Sponsor or EU Legal Representative under the Clinical Trials Regulation. CTA via CTIS, trial insurance, SUSAR reporting, GCP compliance across participating member states. A Qualified Person for batch certification and release named on a Manufacturing and Import Authorisation for IMPs.
The Business Case Comes First
A significant number of EU market entry programmes run into delays that could have been identified earlier. Clinical data acceptable to the FDA may need bridging for EMA. A PIP may be required. CMC documentation may require EU-specific elements that take months. Manufacturing sites may need inspections or CEP filings. And the commercial case, once pricing, reimbursement, launch sequencing, and distribution are factored in, may look very different from the initial projection.
We have structured our approach around EU Readiness Checks that answer these questions before significant investment is committed.
| Readiness Check | What it covers |
|---|---|
| CMC / GxP | CMC dossier against EU expectations, GMP compliance status, supply chain dependencies, technical quality agreements, post-approval variation planning. Output: gap analysis with prioritised action plan. |
| Clinical Evidence | Clinical data fitness for EU regulatory evaluation, evidence gaps, bridging approaches, CTIS readiness, GCP compliance. Scientific Advice preparation where needed. Output: suitability report and recommendations. |
| Regulatory Strategy & Market Access | Submission route, PIP/ODD requirements, SME status, ERA, Module 1 documentation, EMA portal onboarding, EU HTA evidence planning. Pricing strategy, reimbursement pathway assessment, launch sequencing, international reference pricing (IRP) impact analysis, market sizing, and distribution/3PL planning for target markets. Output: regulatory and commercial roadmap with timelines. |
In some therapeutic areas, the evidence package must also satisfy HTA requirements alongside the regulatory submission. Since January 2025, the EU HTA Regulation requires Joint Clinical Assessments for new oncology products and ATMPs, with additional areas phasing in from 2028 and full scope by 2030. Comparator selection, endpoint choice, and subgroup analyses need to account for what HTA bodies will ask, not only what EMA requires. We work with a market-leading EU HTA consultancy to integrate this planning into the readiness assessment from the outset.
For companies evaluating whether and how to enter Europe, these readiness checks are the most cost-effective starting point. They answer the strategic question before the operational investment begins.
One Partner For Two Paths
The regulatory pathway differs fundamentally between pharmaceuticals and medical devices. For pharma: readiness assessment, dossier adaptation, MAH setup, compliance role appointments, MIA/WDA applications, marketing authorisation, pricing and reimbursement, launch. For devices: classification, Legal Manufacturer or EC REP decision, QMS, technical documentation, Notified Body conformity assessment, EUDAMED/UDI, CE marking.
Our pharma and device regulatory teams work under one roof. Combination products, drug-device combinations, companion diagnostics, and products that span both frameworks are handled by a single project team.
Beyond the EU: UK and Switzerland
Since Brexit, the UK requires separate MHRA registration, a UK Responsible Person for import and UKCA or CE marking under transitional arrangements. The MHRA is consulting (closes 10 April 2026) on indefinitely recognising CE-marked devices. Switzerland requires a Swissmedic establishment licence; the EU-Switzerland MRA on devices lapsed in 2021, so separate conformity assessment may be needed. We hold a Swissmedic establishment licence through our Swiss entity. The practical approach is usually to establish the EU base first (typically Germany or Ireland for pharma, Germany for devices), then extend to the UK and Switzerland.
How We Work
Our offices in Germany, Portugal, UK, Ireland, and Switzerland hold their own Manufacturing and Import Authorisations, a Swissmedic establishment licence, and ISO 13485 certification where applicable. We employ QP, QPPV, RP, PRRC, DIO, and Stufenplanbeauftragter directly, as required. Through regulanet®, we coordinate local regulatory and pharmacovigilance services in 90+ countries.
We have supported EU market entry for pharma and device companies from the US, China, Japan, India, South Korea, Canada, and the Middle East. A typical engagement begins with a readiness assessment covering the regulatory, clinical, CMC, and commercial dimensions of the EU opportunity. That assessment may confirm the path is straightforward, identify gaps that need to be closed before submission, or in some cases conclude that the commercial case does not yet support the investment. From there, we provide the regulatory execution (dossier adaptation, authority interactions, submission management), the compliance infrastructure (MAH, QP, QPPV, and the other named roles), and the market access planning (pricing, reimbursement, HTA evidence strategy) through to launch and ongoing lifecycle management. For market access and HTA, we work in partnership with a market-leading EU HTA consultancy.
The team that runs the readiness assessment is the same team that executes the programme and manages the ongoing compliance. Handovers between project phases do not involve handovers between organisations.
Key services
For the operational detail of how each service works, including workstreams, deliverables, and example projects, see the individual service pages.
Regulatory Compliance Roles & Legal Representation
MAH holding (EU, UK, CH), QP, QPPV, RP, PRRC, EC REP, Legal Manufacturer, EU Sponsor.
Regulatory Strategy & Operations
Submission route selection, dossier adaptation, Scientific Advice, PIPs EMA/national authority interactions, eCTD, lifecycle management.
Quality & Compliance
GMP/GDP compliance, QMS setup (pharma and device), MIA/WDA applications, audit readiness, supply chain compliance.
Pharmacovigilance & Device Vigilance
EU QPPV, PSMF, safety database, local PV contacts across EU/CEE via regulanet®, case processing, signal detection.
Clinical Development
Evidence gap analysis, bridging study design, Scientific Advice packages, CTIS support, EU Sponsor role.
Market Access & HTA Strategy
EU HTA Regulation alignment (JCA evidence planning), pricing and reimbursement strategy, launch sequencing, IRP analysis, value dossiers. In partnership with a market-leading EU HTA consultancy.
Medical Device Regulatory Services
MDR/IVDR classification, technical documentation, Notified Body management, EUDAMED/UDI, international registration.
Example Projects
Chinese biosimilar: aligning development with EU requirements
Reviewed the full development package for a Chinese biosimilar company, assessing whether the development strategy (conducted primarily in China) was consistent with EU biosimilar guidelines. Prepared and managed three EMA Scientific Advice procedures, including strategic input on clinical, PK/PD, and analytical comparability questions. The client now has a development path fully aligned with EU requirements.
US biotech: CTA rejection turnaround
A US company developing a therapy for a rare neurodegenerative disorder had a First-in-Human CTA rejected after submitting without sufficient regulatory preparation. We initiated EMA Scientific Advice, reshaped the CTA, and secured CTIS approval. Subsequently retained for PIP, Orphan Drug Designation, a second CTA, and pharmacovigilance system establishment.
Non-EU pharma: five-market EU launch
Three marketed products, no EU entity. We took on the MAH, appointed QPPV, Stufenplanbeauftragter, QP, RP, and DIO for Germany, and coordinated local QPPVs in France, Italy, and Spain via regulanet®. Five-market launch within six months under a single contract.
US Biotech: QP certification for Clinical Trial in EU
Supported client with strategic advice, supplier Audits, QP declarations and QP certification for their oncology target Phase I clinical trial in Europe. Continuing to support this client as they move forward with this project.
US Pharma: New product Launch EU
New product with orphan drug designation for launch in the EU. Supported the client with their own infrastructure set up in Ireland including a gap assessment of their Quality Management system against EU requirements, support during the successful application and associated competent authority inspection from the HPRA (Health Products Regulatory Authority) for their Manufacturing and Importation Authorisation (MIA) and providing the ongoing Qualified Person (QP) support required.
Tell us about your product, where it is in development, and which markets you are targeting and we will come back to you to discuss where we can help.
Contact usFrequently Asked Questions (FAQ)
We have FDA approval. How much work is it to get EU approval?
It is never just a format conversion. Clinical data may need bridging, CMC documentation almost always requires EU-specific elements, paediatric requirements are different, Module 1 is entirely different, and the operational infrastructure must be built from scratch if you have no EU presence. Our EU Readiness Checks quantify exactly what needs to be done before you commit. Most companies find the gap is manageable but larger than expected.
Do we need an EU entity to hold the marketing authorisation?
Yes. The MAH must be established in the EU or EEA. You can either establish your own entity or use a partner as your EU MAH. We act as MAH on our own licences in Germany, UK/Ireland, and Switzerland, which is typically faster for companies entering Europe for the first time.
What is the difference between an EC REP and a Legal Manufacturer?
An EC REP is a liaison between the non-EU manufacturer and EU authorities; the manufacturer retains all MDR obligations. A Legal Manufacturer takes on the obligations directly: CE marking, technical documentation, Notified Body relationship, post-market surveillance. The Legal Manufacturer model is the right choice when the non-EU company does not want to build its own EU device QMS.
What is different about working with a specialist firm rather than a large CRO?
The first question most companies entering Europe need answered is not "who will run the submission" but "does our product have a viable path to EU approval, and what will it actually cost?" That assessment, covering regulatory, clinical, CMC, and market access readiness, is what we lead with. It happens before any commitment to a full-scale engagement, and it includes the commercial dimension: whether the evidence you have will satisfy not only EMA but the HTA bodies that determine pricing and reimbursement. If the path is viable, we provide the full execution on our own infrastructure, with our own named compliance roles, under a single relationship. If the dossier needs significant work first, we say so before you have invested in a submission that will not succeed.
What is the EU HTA Regulation?
Regulation (EU) 2021/2282 introduces mandatory Joint Clinical Assessments at EU level. Since January 2025, these apply to oncology and ATMPs, with additional areas from 2028 and full scope by 2030. National HTA bodies must use the EU-level clinical assessment as a basis for their pricing and reimbursement evaluations. The practical implication is that the evidence package must be designed for both EMA and HTA from the outset meaning that regulatory and market access need to be working hand in hand.
What changed for biosimilars in Germany in 2026?
The new §40c AM-RL substitution regulation entered into force on 1 April 2026, allowing pharmacy-level substitution between a reference biologic and its biosimilars (finished dosage forms). The first biosimilar tenders were published in February 2026. This changes the market entry calculation: the retail segment shifts from a prescription-driven model to a generic-style model, reducing barriers for companies without established EU commercial operations.