Placing on the market (EU)

Placing on the market & Market access (EU)

Your gateway to the EU pharmaceutical market.

MediFirst Pharma makes medicinal products supply-ready across the EU - with clear roles, documented processes, and governance that unites quality, compliance, and distribution along defined interfaces.

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 Set MediFirst.

Placing on the market is system work for us. The European pharmaceutical market is highly regulated - and that is precisely its strength. For international partners, however, this often creates an operational bottleneck regarding role models, evidence management, and QA/QP logic. MediFirst Pharma bundles these requirements in a structured setup so that your market entry becomes predictable and legally secure.
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