Before a product crosses a border, it needs to speak the language of that market’s regulators. Many expansion failures begin here – not with a bad product, but with documentation that was never designed for the destination.
We partner with specialized regulatory consultants to assess MDR/IVDR/ANVISA alignment, IFU multilingual consistency, PMS documentation, and bilateral compliance gaps — so by the time commercial development begins, the regulatory foundation is solid.
Particularly relevant for companies in regulated industries: MedTech, IVD, Life Sciences, Food & Beverage, Agritech, and any sector where product certification or import documentation is a gating factor.
A fixed-scope, time-bound engagement that gives you the market intelligence to make a real decision — not a hopeful one.
Deliverables: segmentation, competitive landscape, reference pricing, localization models, distributor profile scouting, alternative business models, Go-to-Market plan.
BAFA-certified: up to 85% reimbursement for eligible German SMEs.
We identify, qualify, and approach distributors, channel partners, and institutional allies – with negotiation support grounded in local market fluency, not assumption.
Deliverables: pre-qualified partner longlist, facilitated introductions, value proposition adaptation, channel model definition, negotiation support.
An experienced KOMPASSIUM partner operates as your fractional commercial leader – representing your brand, managing relationships, and driving the first revenue cycles.
Minimum 6 months. Monthly steering committee. Quarterly go/no-go reviews.
Modalities: Standard (3–6 days/month) · Intensive (8–10 days/month) · Full-time (15+ days/month)
Since May 1st, 2026, the EU-Mercosur Agreement has created a structural window for companies on both sides of the Atlantic to rethink their international presence.
Europe is actively seeking to diversify trade partnerships.
Mercosur and the broader LATAM region are open for credible, committed partners – not tourists.
KOMPASSIUM has legal entities in Germany and Brazil, partners in 17+ countries, and a track record of executed–not just proposed–market entries.
(examples)
The European Precision Manufacturer
You have a product with proven results at home. You’re looking at LATAM, Africa, or Southeast Asia as the next growth frontier – but you don’t know who to trust, what the market actually pays, how competitors play there, or which distributor will actually sell.
The Brazilian Company Ready for Europe
You’ve built something that works. The EU is known as an advanced market and can be a natural next step. You need a partner who understands both sides — the regulatory landscape, the buyer psychology, and the commercial model that will survive first contact with the market.
The International Company Entering a Regulated Market
Your product needs more than a sales partner. It needs regulatory clarity, documentation alignment, and a commercial development sequence that doesn’t break when the first compliance question is asked.
BAFA – the Bundesamt für Wirtschaft und Ausfuhrkontrolle – is the German federal authority that subsidizes, among other services, consulting engagements for small and medium-sized enterprises. Through its SME consulting program, eligible companies can receive a 50% to 85% reimbursement of qualified consulting fees.
Eligibility covers established German SMEs and companies that have recently registered a legal entity in Germany. If your GmbH is less than one year old, one additional step applies: a brief mandatory information session at your regional IHK or Handwerkskammer before the application.
One requirement applies to everyone: BAFA approval must be obtained before the project begins. Retroactive applications are not accepted.
KOMPASSIUM is a BAFA-listed consulting partner, nº 220796
We are a pre-qualified consulting provider, and we guide you through the application process before we start working together.
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