Lab services
Linneo is widening its services portfolio to provide state-of-the-art Laboratory Services in one single contract, one-stop-shop to reduce administrative costs and time.
Company overview
Linneo Health is a pioneering pharmaceutical company in the medicinal cannabis market. We have become a global leader in the research, production and distribution of cannabis for medical use.
Our facilities and production processes comply with European manufacturing standards EU – GMP and GACP. Our laboratory, one of the most advanced in Europe, allows us to comply with the most rigorous quality control standards globally.
We have one of the most sophisticated and well-equipped EU-GMP certified analytical parks in the industry. We also have a highly qualified and committed technical team with extensive experience in the sector.
Our facilities and production processes comply with European manufacturing standards EU – GMP and GACP. Our laboratory, one of the most advanced in Europe, allows us to comply with the most rigorous quality control standards globally.
We have one of the most sophisticated and well-equipped EU-GMP certified analytical parks in the industry. We also have a highly qualified and committed technical team with extensive experience in the sector.
Our Laboratory Services
Irradiation Process Validation
In collaboration with Ionisos*, we offer an integrated solution that combines irradiation and analytical services. We coordinate the entire project, including intercompany transport and waste management.
*Ionisos Ibérica is a company specialized is the irradiation of Cannabis flowers. Ionos and Linneo have a partnership to provide combined solutions for irradiation and analytical services. Linneo and Ionisos are fully independent companies.
- Dose Finding
- Dose Mapping
- Process Validation
- Associated analytical testing
- A single, fully coordinated solution
Quality Control – Comprehensive Analyses
We perform full testing of Cannabis flower and extracts using verified Ph. Eur. methods and validated in-house methods, including:
- Identification
- Content / Impurities
- Moisture (LOD / Karl Fischer)
- Residual solvents
- Heavy metals
- Pesticides
- Terpenes
- Mycotoxins
- Full microbiology
Regulatory Support
Experts in preparing AMRadV dossiers for Germany and in providing regulatory consulting throughout the entire product lifecycle. We will assess the available documentation and determine what additional information is needed, guiding the client through the process.
- Review of available documentation: We evaluate all existing information and advise on the required adaptations
- Creation of new documentation: We prepare or provide any missing documents needed to complete the dossier
- Compilation and submission of the dossier: We prepare the file in eCTD format and coordinate its submission to the German authorities
- Follow-up: We manage responses to BfArM requests during the evaluation.
Stability Studies
- We conduct studies in accordance with ICH Q1A(R2) to ensure the stability of medical cannabis products intended for any international market.
Quality control Cannabis-based products (according to DAB and Ph. Eur.)
Physico chemical analyses
- Macroscopic and microscopic identification/foreign matters / cannabinoid content analyses by HPLC-DAD and HPLC
- Cannabinoid profile identification by HPLC-DAD: delta-9-tetrahydrocannabinol (THC), delta-9-tetrahydrocannabinolic acid (THC-A), cannabidiol (CBD), cannabidiolic acid (CBD-A), delta-8-tetrahycrocannabinol (THC). cannabinol (CBN), cannabichromene (CBC), cannabichromene acid (CBCA), canaigre (CBG), cannabigerol acid (CBGA), delta-9- tetrahydrocannabivarin (THVC), cannabidivarin (CBDV)
- Determination of Moisture by Loss on Drying in Vacuum Oven and Karl Fisher
- Mycotoxin Analyses: Aflatoxins and Ochratoxin A • Heavy Metals: Cadmium, Mercury, Lead, Arsenic, Niquel and Zinc • Total Ash and Sulfuric Ash • Analyses of pesticides: multiresidue pesticides • Terpene profile. MICROBIOLOGICAL ANALYSES • Mold and Yeast (TYMC) • Total Aerobes (TAMC) • Enterobacteria, Pseudomonas aeruginosa, Staphyloccoccus aureus, Escherichia coli, Salmonella spp, Shigella spp, Listeria Monocytogene
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
For further information about how we can help, please contact