Our Services
From formulation to certification — pharmaceutical expertise for the cannabis industry.
MD Device Certification
Regulatory support in accordance with MDR 2017/745
We assist with the certification of cannabis-based medical devices in accordance with the European Medical Device Regulation. Our team provides support with product classification, risk analysis, technical documentation, and the entire conformity assessment process through to CE marking.
- Classification according to MDR Annex VIII
- Technical Documentation & Risk Analysis
- Clinical Evaluation & Post-Market Surveillance
- Cooperation with Notified Bodies
Galenic development
Programs developed in collaboration with universities
In close collaboration with pharmaceutical institutes at German universities, we develop innovative dosage forms for active cannabis ingredients. From formulation development and stability studies to process validation.
- Extracts, capsules, and oral formulations
- Transdermal systems & suppositories
- Stability studies in accordance with ICH guidelines
- Scale-up & Process Validation
Supply Chain Management
From the source to the pharmacy
We manage the entire value chain for medical cannabis—from identifying and qualifying growers to GMP-compliant processing and GDP-compliant distribution. Every step is documented and traceable.
- Supplier Qualification & Auditing
- GMP-compliant processing & analysis
- GDP-compliant Logistics & Distribution
- Complete traceability & documentation
Regulatory Consulting
GMP, GDP, and Cannabis-Specific Compliance
Comprehensive consulting services for all regulatory requirements in the cannabis industry. We assist with the implementation of quality management systems, help prepare for inspections, and guide you through the entire certification process.
- GMP/GDP Implementation & Certification
- Quality Management Systems (QMS)
- Inspection Preparation & Mock Audits
- Import & Export Licenses
Our Approach
Structured, scientific, results-oriented.
Analysis
Assessment of your current situation and regulatory requirements.
Strategy
Development of a customized roadmap with clear milestones.
Implementation
Hands-on support from our team of experts—both on-site and remotely.
Validation
Documentation, verification, and compliance with all regulatory standards.
Frequently asked questions
What does GDP-compliant logistics mean at Nexopharm?
GDP (Good Distribution Practice) is the EU standard for distributing medicinal products. At Nexopharm every shipment is temperature-controlled, fully documented and delivered through a qualified wholesale operation under § 52a AMG — including validated transport routes and a GDP-compliant complaints and emergency process.
What does GMP quality assurance stand for?
We rely on EU-GMP-compliant processing with final release by a Qualified Person. Every batch receives a Certificate of Analysis to DAB and Ph. Eur., including screening for heavy metals, pesticides and mycotoxins, plus complete batch documentation.
Does Nexopharm offer galenic development?
Yes. Working with pharmaceutical institutes at German universities, we develop cannabis-based dosage forms — from formulation development and ICH-compliant stability studies to scale-up and process validation.
Does Nexopharm support MDR certification of medical devices?
We support cannabis-based medical devices under MDR 2017/745 — from classification under Annex VIII and technical documentation and risk analysis to cooperation with notified bodies and CE marking.
Who are Nexopharm’s services intended for?
For pharmacies, pharmaceutical manufacturers and distributors, and for cannabis-prescribing physicians in Germany. All services are geared towards regulated, GMP-/GDP-compliant supply chains.
Discuss the project
Talk to us about your next certification or product development project.
Get in touch