Specialized Manufacturing & GMP Compliance

Strategic GMP consulting for medical cannabis, manufacturing pharmacies, and emerging pharma markets. Bridging the gap between specialized production and rigorous EU-GMP standards.

A split image shows a close-up of a section of a cannabis leaf on the left and a modern, well-lit pharmacy interior with glass display cases and shelves filled with medication on the right.

"The Regulatory Vacuum" In emerging sectors, quality is often driven by passion, but hindered by bureaucracy. Most consulting firms focus on established giants. We focus on you: the specialized producer. We don't just provide templates; we build the regulatory backbone that allows your innovation to be legally compliant and commercially viable.

Medical Cannabis

In the evolving medical cannabis market, the challenge is not just cultivation—it is the transition to a pharmaceutical-grade product. We build the regulatory bridge between GACP and EU-GMP.

  • QMS Implementation: Designing robust Quality Management Systems tailored to the unique lifecycle of cannabis.

  • Process Validation: Ensuring extraction and refinement processes meet the highest purity standards for final release.

  • Investor Security: Creating audit-ready documentation that transforms a startup into a compliant pharmaceutical entity.

Compounding & Manufacturing Pharmacies (Switzerland)

Swiss pharmacies are shifting from traditional compounding to specialized small-scale manufacturing. This transition requires a shift in mindset: from artisanal craft to rigorous GMP-compliance under Cantonal and National oversight.

  • Facility Qualification: Adapting existing pharmacy infrastructure to meet sterile and non-sterile manufacturing requirements.

  • Documentation Frameworks: Developing a robust QMS and SOPs that reflect the reality of specialized pharmacy operations.

  • Inspection Readiness: Direct support for Cantonal Pharmacist (Kantonsapotheker) audits through proactive gap analysis.

Emerging Markets & Global Entrants

Manufacturers in emerging markets possess the capacity but often lack the regulatory alignment required for GMP approval. We act as your local expert partner to ensure your facility meets the highest global expectations.

  • Gap Analysis & Roadmapping: Identifying the critical differences between local standards and GMP requirements.

  • Digital Transformation: Replacing legacy manual systems with modern, data-integrity-compliant QMS and all necessary structures.

  • Remote & On-Site Auditing: Rigorous pre-inspections to ensure your team is prepared for official regulatory scrutiny.