END‑TO‑END PHARMACEUTICAL MARKET ENTRY

Common Hurdles

• Aligning your portfolio with European market opportunity, pricing and competitive dynamics; deciding which indications to launch first and how to scale.
• Building a sound business model for German tender markets: Selecting the right go‑to‑market model, combining tender strategy with distribution channels and aligning with budgetary and reimbursement frameworks.
• Planning entry with predictable costs and return on investment.
• Determining whether your medicine fits the EMA’s centralised procedure or should follow decentralised, mutual‑recognition or national pathways across EU and EEA member states.
• Evaluating whether existing clinical and quality data meet EU standards and identifying where bridging studies or additional documentation are needed.
• Establishing a compliant presence: Appointing an EU‑based MAH/authorised representative and securing importation, batch‑release and distribution licences.
• Achieving full alignment with EU GMP and complementary standards (GDP, GCP, ISO 9001) and ensuring QP release for every imported batch.
• Navigating Europe’s fragmented market, where reimbursement, pricing, timelines and healthcare systems differ across 27+ countries - each with its own language, payer expectations and patient needs.

How We Support You

Strategy, Commercial & Portfolio Advisory
We help define your European entrance strategy and build the business case for market entry. We assess portfolio and product selection by country, analyse market potential and pricing climates, and advise on which indications offer the greatest opportunity and in what sequence. Our team brings hands‑on experience building and scaling European organisations for Chinese and Indian companies. We support pricing and reimbursement planning, prepare Joint Scientific Consultation dossiers and (EU) Health Technology Assessment submissions, and design phased investment models to minimise risk. This guidance helps you decide whether to pursue a POC launch or a full entry and to structure a scalable market model.

Organisational Setup and Quality
We design and implement manufacturing strategies and establish CMC and quality management systems aligned with EU GMP, GDP, GCP, and ISO 9001. For combination products, we additionally apply ISO 13485.

Our team supports pre-clinical and clinical study operations, supply chain management, and Qualified & Responsible Person services. We obtain wholesale distribution, manufacturing, and import authorisations, conduct GxP audits, and oversee supplier qualification and supervision.

Through our plug-and-play framework, you can launch products under our existing licences, qualified personnel, and quality systems, or establish your own infrastructure when ready. This setup minimises risk, avoids fixed investments, and allows a seamless transition to a permanent European subsidiary when the time is right.

Regulatory Strategy and Implementation
We classify your product and select the appropriate registration route (CP, DCP, MRP or national). We compile CTD/eCTD dossiers and CEP/EDQM applications, coordinate scientific advice and PIP procedures, prepare and submit marketing authorisation applications, variations and renewals, and manage interactions with EMA and national authorities. Our track record includes more than 45 marketing authorisation applications across centralised, decentralised, mutual‑recognition and national procedures, over 1000 variations and 30 renewals, and more than 40 periodic safety update reports; we have held more than 100 marketing authorisations on behalf of our clients. We provide regulatory strategy and gap analyses and can engage on specific tasks such as authority communications, lifecycle variations, QP release or reimbursement submissions for companies that already have an EU presence.

Development Support and Evidence Generation
We evaluate your existing clinical, non‑clinical and CMC data, identify gaps and design bridging or supplemental studies to meet EU requirements. We advise on pre‑clinical and clinical programmes to align with EU regulatory and market access expectations and prepare the corresponding modules of the CTD. We coordinate CEP/EDQM filings and joint scientific consultations and support health technology assessments to ensure evidence packages are fit for approval and reimbursement.

Integrated Support and Local Expertise
We bring together regulatory, clinical, CMC, market access and commercialisation expertise under one framework to support you across development, authorisation and market entry. Our regulanet® network provides local execution in more than 90 countries; we have particular expertise in Germany’s tender market and have built and scaled European organisations for clients via acquisitions, marketing authorisation transfers and new MA development. One project lead and contract coordinate all activities, with clear accountability and minimal burden on your team. We handle pharmacovigilance, act as EU QPPV, manage PSUR and post‑approval variations and oversee batch release and MA maintenance. Our teams operate in German, English and French, and we provide bilingual Mandarin–English support.

Example Pathway to EU Entry

*Durations are indicative; actual times vary with product type, dossier readiness, regulatory pathway, market access complexity.

Why Choose regenold?

• End‑to‑end partner: We integrate strategy, regulatory affairs, CMC, clinical development, market access and commercialisation to guide your products from concept through approval, launch and post‑approval.
• Risk‑managed entry: Our plug‑and‑play framework lets you test the EU market without building your own infrastructure, ensuring investment security and predictable budgets.
• Strategic insight: We help you select the right products, design the business case and market model, plan tender strategies and pricing, and build or scale your European organisation.
• Proven regulatory execution: With 45+ marketing authorisation applications, 1000+ variations and 40+ scientific advice meetings, we have extensive experience across EMA and national procedures.
• Local expertise, global reach: our network regulanet^® spans over 90 countries; one contract and project lead ensure coordinated local actions.
• Lifecycle accountability: We support development, submission, market entry and post‑approval; we can also support specific tasks for clients with existing EU operations.
• Multilingual communication: Teams operate in German, English and French, with bilingual Mandarin–English support to ensure clarity and cultural alignment.
• Market access and commercialisation expertise: Our network includes market access and commercialisation specialists who work alongside regulatory teams. By combining regulatory, market access and commercialisation strategies, we create market advantage—ensuring tender strategies, pricing and distribution models are aligned with approval timelines and payer requirements.