CMO Services
Linneo Health acts as your EU-GMP CMO for the processing, conditioning and batch release of medical cannabis, integrating quality, traceability and compliance across every stage. A centralized model providing greater control and a more efficient regulatory pathway.
Post-harvest handling in a pharmaceutical environment
GACP/GMP material is managed within an EU-GMP environment under validated procedures, in controlled areas and with full documentary traceability. This approach ensures material integrity and batch-to-batch consistency. Conditioning, packaging and labelling are carried out in classified areas, using approved formats and in compliance with the regulatory requirements of the destination market.
Pharmaceutical Transport and Logistics Management
We manage logistics through specialized partners in the transport of pharmaceutical products and controlled substances, ensuring regulatory compliance at every stage. Each shipment is coordinated under validated conditions of temperature, security and documentation, fully aligned with the regulatory requirements of the destination country.
Quality Control and Batch Release (QP)
Our specialized technical team, with experience in regulated environments, ensures the proper execution and oversight of all quality control activities in accordance with a GMP system. Comprehensive analyses are performed at our facilities, followed by a QP declaration confirming GMP compliance of the processes carried out.
Technical and Regulatory Support
Support for documentation, stability programs, specifications and country-specific requirements within the European Union.
Ph. Eur. methods verified according to Chapter 5.26 Ph. Eur. In-house Analytical Methods validated according to ICH Q2(R2)
What makes us different
Experienced and multidisciplinary team: our experience enables us to offer added value to our clients, contributing knowledge, expertise and resources from the beginning of the process through to registration and marketing.
We have a specialized Quality and Regulatory Affairs unit, comprised of professionals with extensive experience in national and multinational companies in the pharmaceutical sector.
We offer a complete service, including the coordination of the project between Linneo and Ionisos, including the transport of the samples between both companies, thus reducing logistics costs and bureaucracy. You will have a single interlocutor and a single contract.
We work to maximize the potential of the collaboration: we share knowledge and benefits with our business partners to create a solid and fruitful relationship.
Certificates
