The American Gateway — out now
The outbound playbook for European pharma crossing the Atlantic: how to enter, price and win in the world's largest and most rule-bound drug market. Book One of The Pharma Gateway Series.
Read →Practical guides on entering Germany and the EU — from the reimbursement and regulatory questions that decide life-sciences revenue to the strategy, cost and distribution of market entry. Filter by what you need.
The outbound playbook for European pharma crossing the Atlantic: how to enter, price and win in the world's largest and most rule-bound drug market. Book One of The Pharma Gateway Series.
Read →Not a filing manual — the missing explanation of why German tax works the way it does, for anyone who met the system before they understood it.
Read →A practical playbook for structuring, warehousing and scaling an e-commerce business across the EU — and a candid look at the mistakes that quietly cost the most.
Read →Germany is Europe's biggest online market and one of its most sceptical. How to earn its trust — the digital-marketing, credibility and market-entry playbook.
Read →The G-BA benefit assessment, the IQWiG comparator, and why the added-benefit rating — not your home price — sets the ceiling on German revenue.
Read →A CE mark lets you sell; it doesn't get you paid. How DRG / NUB and G-BA / EBM decide medtech reimbursement by care setting.
Read →Germany's app-on-prescription route through the BfArM fast-track — and why a listing is not the same as a prescription.
Read →Three gatekeepers, one budget: how the drug commission, the hospital pharmacy and the department budget decide formulary access — long after approval.
Read →Approval is only the entry ticket. What actually decides revenue after it — and why getting paid is a separate project.
Read →Centralised, decentralised, mutual-recognition or national — the four paths to a German marketing authorisation, and how to choose the right one.
Read →One system, two approvals: how the BfArM/PEI authorisation and the ethics-committee vote run under the EU Clinical Trials Regulation.
Read →The licence to actually supply: the AMG manufacturing and import authorisations, the QP release and the GMP duties behind every batch sold in Germany.
Read →Medical devices and in-vitro diagnostics run on different regimes with different classes — and the answer changes everything downstream.
Read →GDPR, BfArM's data-security requirements and the BSI certificate — the most underestimated hurdle for non-EU digital-health companies.
Read →The continuing duties of a marketing-authorization holder: pharmacovigilance, GMP / GDP and the officers you're required to appoint.
Read →How to identify and approach the partners who actually move product — not the ones who merely hold a business card.
Read →German hospital procurement is committee-driven and slow. How access really works through purchasing groups, clinic chains and tenders.
Read →How prescription supply reaches Germany's ~18,000 pharmacies under GDP and EU serialization — and why the channel differs by product type.
Read →What Korean pharma, medtech and digital-health companies need to know before entering Germany and the EU.
Read →The outbound direction: how German life-sciences companies take products and equipment to markets abroad.
Read →The diversification play: navigating ASEAN's regulatory patchwork, choosing a lead market and building the route into Southeast Asia.
Read →ANVISA registration, mandatory local representation and the regulatory path into Latin America's largest healthcare market.
Read →Strategy, tax and structural risks for US companies establishing a presence in Germany.
Read →The full field guide for US life-sciences startups — the EU footing (Rep/PRRC, MAH/QPPV), both regulated tracks (MDR/IVDR and drug authorisation), and AMNOG, DRG and DiGA reimbursement.
Read →Next door, but a third country: why Swissmedic isn't the EMA, the lapsed EU–Swiss device MRA (and the not-yet-in-force 2026 update), the EU footing you need, and AMNOG / DRG reimbursement.
Read →The outbound corridor to India — legal vehicles, the FDI route, CDSCO device licensing and the sequence that actually works.
Read →SFDA registration, the local-agent rule and why NUPCO and Vision 2030 reward localisation on the KSA corridor.
Read →NMPA registration and the mandatory local agent, plus the volume-based procurement that sets your price — and why the smart move is China alongside a hedge, not all in.
Read →TITCK, the UTS gate and a Euro-referenced price capped by a managed lira rate — why full access in Turkey tends to follow local production.
Read →Five criteria, six corridors and a scorecard — how to compare China, India, Brazil, Southeast Asia, Turkey and Saudi Arabia, and sequence two or three instead of betting on one.
Read →The starting point: how entry, regulation and the business environment fit together for companies coming into Germany and the EU.
Read →Choosing your entry mode — distributor, branch or GmbH — and the strategic decisions before you commit.
Read →Once you're set up — distribution, sales channels and why being authorized isn't the same as getting paid.
Read →IT, pharma, logistics and construction — how the entry playbook differs across sectors.
Read →BDI, the DIHK / IHK chambers, VDMA, Bitkom and the trade fairs (MEDICA, Hannover Messe) that are often a foreign company's first route into German industry.
Read →Setup, regulatory, QMS and access costs a medical-goods company should budget — including the ones most underestimate.
Read →How to structure a German investment — tax, holding options and a market-entry review.
Read →What running a business here is actually like — the environment, employment rules, compliance and business culture once you're operating.
Read →If your product is regulated, a short session turns these questions into a plan built for your case.
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