Placing on the market (EU)

Placing on the market & Market access (EU)

Your gateway to the EU pharmaceutical market.

Medi First Pharma macht Arzneimittel EU-weit versorgungsfähig – mit klaren Rollen, dokumentierten Prozessen und einer Governance, die Qualität, Compliance und Distribution entlang definierter Schnittstellen zusammenführt.

Placing on the market is not a bureaucratic hurdle, but operational responsibility: We translate regulatory complexity into predictable, auditable process execution.

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Operational responsibility: what we take over

Depending on the role model and project scope, we take over modules along the entire placing-on-the-market chain: from import through QA/QP governance to GDP distribution.

  • Import & placing on the market (EU/DE): Import of medicinal products from third countries pursuant Section 72 AMG including process and documentation logic.
  • QP release / QA governance: release for the EU market by Qualified Persons (QP) based on SOP-driven workflows and defined testing pathways.
  • Wholesale & distribution (GDP): purchase/sale and distribution under GDP logic with documented handovers and traceability to the pharmacy or wholesaler..
  • Regulatory Affairs management of authorisation/registration processes (e.g., BfArM/EMA) depending on product and role model.
  • Pharmacovigilance interfaces (role-based): integration of required reporting and safety processes into the overall logic.

Why partners on Medi First setzen.

Inverkehrbringen ist bei uns Systemarbeit. Der europäische Pharmamarkt ist hochreguliert – und genau das ist seine Stärke. Für internationale Partner entsteht daraus jedoch oft ein operativer Engpass bezüglich Rollenmodellen, Nachweisführung und QA/QP-Logik. Medi First Pharma bündelt diese Anforderungen in einem strukturierten Setup, damit Ihr Markteintritt planbar und rechtssicher wird.
We are particularly strong where standardization and strict process control are crucial - for example with complex natural substance-based starting materials.

Process: how a project with us works

  1. Scope & role model:define responsibilities and interfaces cleanly
  2. Quality & regulatory setup:QMS logic, testing/release pathways, evidence management
  3. Supply chain & distribution:GDP handovers, traceability, operational implementation
  4. Go-live & operations:monitoring, deviation management, continuous improvement

project request

You are planning EU market entry or placing on the market and are looking for a partner for governance, quality, and distribution?

Request a project