ADRESEUROPEAN REGULATORY STRATEGY · FOR US BIOPHARMA & MEDTECH
Make Europe part of the plan—not an afterthought.
A US development or clearance plan does not automatically answer Europe’s regulatory questions. ADRES helps biopharma and medical device teams identify the appropriate EU route, close evidence and quality gaps, and prepare for the next authority or notified-body milestone.
Campaign offer: free 45-minute introductory call, followed by a complimentary one-hour expert meeting.
WHERE TO BEGIN
The EU path should fit the product—not a template.
For medicines and biologics, the work may involve EMA advice, clinical and CMC evidence, and submission strategy. For medical devices, the focus may be classification, applicable EU MDR requirements, clinical evaluation, technical documentation, notified-body engagement, and CE-marking preparation.
ADRES brings regulatory and quality perspectives together to define what must be decided now, what US evidence may be reused, and which gaps need action before the next EU milestone.
EU pathway and gap assessment
Map the medicinal-product or device route, relevant requirements, evidence gaps, and decisions for your stage.
Agency or notified-body planning
Prepare questions and supporting rationale for EU authorities, or for notified-body discussions when relevant to a device.
Dossier or technical-file readiness
Align cross-functional input and documentation for the next submission, technical file, or CE-marking milestone.
QUESTIONS WORTH RESOLVING EARLY
The path depends on the product.
There is no single EU playbook for every US life-sciences product. The right work starts with the details.
- How should US evidence and regulatory decisions be evaluated against the applicable EU route?
- Is authority advice relevant for a medicine, or notified-body engagement for a device?
- What clinical, performance, quality, CMC, or technical-documentation gaps need attention?
- What is the sequence of decisions, meetings, submissions, or CE-marking milestones?
- Who owns each workstream across internal teams and external partners?
HOW THE ENGAGEMENT CAN WORK
Start narrow. Build a plan you can use.
Share your program
Tell us the product type, stage, US status, available evidence, and the European decision you need to make.
Identify the gap
We review the product-specific question and define the most useful initial regulatory or quality work.
Move to execution
Build a practical roadmap, then support the meetings, evidence, and documents that follow.
COMMON QUESTIONS
EU planning, without the guesswork.
Can we use our US evidence in Europe?
Some elements may be relevant, but suitability depends on the product, evidence, and applicable EU route. A gap assessment can identify where alignment exists and where further work or regulator input may be needed.
Do we need EMA advice or a notified body?
Medicinal products and devices follow different pathways. Authority advice may be useful for a medicine; notified-body involvement depends on a device’s classification and route. We can help assess which interaction matters and when.
Can ADRES help with EU MDR and CE-marking preparation?
Yes. ADRES supports medical device regulatory strategy, EU MDR requirements, technical documentation, and CE-marking preparation. The exact scope depends on the device and its pathway.
CAMPAIGN OFFER
Start with a call. Then pick our brains.
45-minute introductory call + a complimentary one-hour “Pick our brains” meeting with an ADRES expert.
First, introduce your company, product, and European goals. Then bring your specific regulatory questions to a one-hour discussion with an expert matched to your topic—whether you develop a medicine, biologic, or medical device.
Both meetings are free. Use the form below to request your introductory call and expert session.
Request the campaign offer by email →Explore our regulatory affairs and medical device services.
Request your introductory call and expert session
FROM THE ADRES KNOWLEDGE HUB
Explore the questions behind your EU plan.
Choose the reading relevant to your product. PRIME and orphan medicinal product designation apply to medicines, not medical-device CE marking.
EMA SME status: what applies?
Updated guidance on eligibility, ownership, non-EEA access and procedure-specific fee incentives. Includes the limits of MedTech applicability and the distinctions between PIP and PRIME support.
Read the updated SME article ↗Understanding PRIME
An introduction to EMA’s support for promising medicines addressing unmet medical needs. Eligibility and accelerated assessment are not automatic.
Read the PRIME article ↗EU orphan designation
Explore OMPD criteria, application planning, and incentives. Market exclusivity follows qualifying marketing authorisation, not designation alone.
Read the OMPD article ↗AI as a medical device
A notified-body perspective on intended clinical benefit, evidence, performance validation, and the software development lifecycle for AI-based devices.
Read the medical-device article ↗These articles provide background, not a product-specific regulatory assessment. Requirements and procedures can change.
Request your introductory call →