Leaders in European Regulatory Solutions
Europe rewards teams that plan for its structure and punishes teams that treat it as a single agency. The centralised procedure, decentralised and mutual recognition routes, national filings, notified bodies, and the post-Brexit UK pathway each carry different timelines, costs, and negotiating dynamics. We embed senior European regulatory leaders who have run these procedures end to end, so the pathway decision is made deliberately and defended confidently: to your board, your investors, and the agencies themselves.
From the first EMA interaction to the variation that protects your label ten years later, our European practice covers the full arc of a product's regulatory life.
Centralised, decentralised, mutual recognition, or national: pathway selection, orphan and PRIME strategy, and integrated EU development plans.
EMA scientific advice, protocol assistance, and national agency consultations: question strategy, briefing documents, and rehearsal.
Marketing Authorisation Applications authored, reviewed, or fully managed, with eCTD publishing and assessment question support.
CE marking strategy, technical documentation, clinical evaluation, and notified body engagement for devices and diagnostics.
MHRA and Swissmedic pathways, international recognition procedures, and dual-filing strategy for the post-Brexit landscape.
Variations, renewals, line extensions, and safety-driven label changes managed consistently across every market you sell in.
Centralised, decentralised, mutual recognition, or purely national: the procedure you choose determines your timeline, your assessment dynamics, and which regulators you will negotiate with for the life of the product. Some products have no choice; most have more options than their teams realise. We build integrated European plans that weigh procedure selection against your indication, modality, orphan and PRIME eligibility, and commercial launch sequence, then pressure-test the plan the way a rapporteur would.
Scientific advice is inexpensive insurance against a failed assessment, but only when the questions are engineered to produce answers you can act on. Vague questions return vague reassurance; sharp questions return commitments you can build a program on. We formulate the question strategy, author the briefing document, anticipate assessor pushback, and rehearse your presenting team for EMA scientific advice, protocol assistance, and national agency consultations.
A Marketing Authorisation Application is judged twice: once on the data, and once on how findable, coherent, and internally consistent the dossier is. We author or review every module with the assessment report in mind, manage eCTD publishing, and staff the question-response cycle at Day 120 and Day 180, when the clock is stopped and the pressure is highest. The goal is an approval without an oral explanation, and readiness for one if it comes.
The Medical Device and IVD Regulations turned CE marking from a documentation exercise into a continuous obligation: clinical evaluation that must be maintained, post-market surveillance that must produce evidence, and notified bodies with limited capacity and long queues. We plan classification and conformity routes, build technical documentation that survives audit, and manage the notified body relationship so review cycles do not become your critical path.
What used to be a single European submission is now the EU, the UK, and Switzerland, each with its own authority, timeline, and legal representative requirements. Sequenced well, the extra filings are largely reuse; sequenced poorly, they become parallel programs. We plan MHRA and Swissmedic strategy alongside your EU filing, exploit international recognition and reliance procedures where they genuinely save time, and keep your product information consistent across all three markets.
A European authorisation begins a permanent maintenance obligation: variations for every meaningful change, renewals, safety updates, and the slow accumulation of national differences that quietly fragment a label. We run lifecycle management as a discipline, classifying changes correctly the first time, bundling variations to cut cost and review load, and keeping the dossier in a state where the next audit, transfer, or acquisition finds nothing to unwind.
Our fractional regulatory leaders bring decades of EMA, MHRA, and national competent authority experience across scientific advice, submission, and inspection cycles. You aren't being staffed with junior consultants under a partner's name; you get the senior practitioner on every call.
Practitioners who have planned and defended programs before EMA committees, national competent authorities, and notified bodies, and who know how European assessors actually read a dossier.
The lead consultant on your engagement is the one doing the work. We don't bait-and-switch with junior staff after the contract is signed.
Centralised and national procedures, the UK and Switzerland, and the member-state variations in between, managed as one coherent program rather than thirty separate ones.
Small molecule, biologic, cell & gene, medical device, diagnostic, and digital health, across oncology, rare disease, neuroscience, immunology, and beyond.
Tell us where your program stands and which markets matter most. We'll match you with a senior European regulatory lead and respond within one business day. All inquiries are strictly confidential.