Our Services
From formulation to certification — pharmaceutical expertise for the cannabis industry.
MD Device Certification
Regulatory guidance under MDR 2017/745
We guide the certification of cannabis-based medical devices under the European Medical Device Regulation. Our team supports product classification, risk analysis, technical documentation, and the entire conformity assessment procedure through to CE marking.
- Classification under MDR Annex VIII
- Technical documentation & risk analysis
- Clinical evaluation & post-market surveillance
- Cooperation with Notified Bodies
Galenic Development
Formulations in cooperation with universities
In close collaboration with pharmaceutical institutes at German universities, we develop innovative dosage forms for cannabis active ingredients. From recipe development through stability studies to process validation.
- Extracts, capsules & oral dosage forms
- Transdermal systems & suppositories
- Stability studies per ICH guidelines
- Scale-up & process validation
Supply Chain Management
From source to pharmacy
We manage the entire value chain for medical cannabis — from identifying and qualifying cultivators through GMP-compliant processing to GDP-compliant distribution. Every step is documented and traceable.
- Supplier qualification & auditing
- GMP-compliant processing & analytics
- GDP-compliant logistics & distribution
- Full traceability & documentation
Regulatory Consulting
GMP, GDP & cannabis-specific compliance
Comprehensive consulting for all regulatory requirements of the cannabis industry. We support quality management system implementation, prepare for inspections, and guide the entire certification process.
- GMP/GDP implementation & certification
- Quality management systems (QMS)
- Inspection preparation & mock audits
- Import & export permits
Our Approach
Structured, scientific, results-oriented.
Analysis
Assessment of your status quo and regulatory requirements.
Strategy
Development of a tailored roadmap with clear milestones.
Implementation
Hands-on guidance from our expert team — on-site and remote.
Validation
Documentation, review, and assurance of all regulatory standards.
Discuss Your Project
Talk to us about your next certification or product development project.
Get in Touch