Expand to Europe
Our EU platform of services, modular, tailored, and built for biotechs with a 1st medicine.
Shape. Submit. Scale.
Your European Expansion.
From early EU strategy and regulatory development to marketing authorization,
country launches and sustainable operations across Europe.
Shape
Shape your European pathway before pivotal development decisions become expensive to reverse.
Your Goal
Define the optimal European regulatory and evidence strategy, secure available incentives, and align your global development plan with EMA, HTA and market-access expectations.
Our Solution
- A clear, customized EU regulatory roadmap aligned with your global development strategy and key value inflection points.
- Early assessment and management of SME status, orphan designation, PRIME eligibility and EEA establishment requirements.
- Strategic preparation and coordination of EMA scientific advice, protocol assistance, national authority and HTA interactions.
- EU alignment of clinical development, endpoints, comparators, CMC, PIP, RMP, ERA and future access evidence.
- Hands-on preparation for submission, including EMA system readiness, pre-submission activities and validation planning.
Submit
From MAA preparation to EU authorization – and onward to global regulatory expansion.
Your Goal
Prepare and submit a validation-ready European dossier, manage the EMA procedure through CHMP opinion, and maintain control of your authorization throughout its lifecycle.
Our Solution
- EU dossier gap analysis, eCTD compilation and preparation of the SmPC, labelling, package leaflet and pre-submission package.
- End-to-end coordination of MAA submission, validation and the EMA evaluation procedure from Day 0 to CHMP opinion.
- Strategic management and authoring of Day 120 responses, outstanding issues and oral-explanation preparation.
- Parallel coordination of Joint Clinical Assessment requirements and access implications for eligible products.
- Post-authorization lifecycle support and sequenced regulatory expansion into more than 80 international markets.
Scale
Turn your EU authorization into compliant, market-by-market commercial execution.
Your Goal
Establish the local infrastructure, regulatory coverage and operational model required to launch and grow successfully across your priority European markets.
Our Solution
- Country-specific regulatory reports, launch sequencing and clear allocation of responsibilities across your internal and external teams.
- Local operational set-up covering distribution flows, qualified partners, QP and QPPV support, serialisation, product codes and launch notifications.
- Preparation of educational materials, local registrations, early-access activities and pricing and reimbursement dossiers.
- A centralized EU promotional-review platform covering regulatory and medical review, local codes and market-specific approval requirements.
- Access to local responsible persons and signatories, with ongoing coordination and lifecycle support across your target markets.
Join the Expert Q&A Series
Critical Knowledge. Real Experts. Your Questions.
Access concise, high-impact PDFs where seasoned specialists share decades of experience helping biotech companies enter and thrive in the European market.
Each edition covers essential themes, navigating EU regulatory pathways, accelerating patient access, and building a sustainable European presence, so you avoid missteps and move forward with clarity.
This is an interactive series – your questions shape the content, ensuring every edition addresses the real-world challenges of expanding into Europe.
