LEF offers its vast know-how in method development and validation, quality control, compliance, and regulatory consultancy, strengthening its position as a partner and service provider for the Pharmaceutical Industry since 1992.
The extensive experience and consolidation of LEF as a one-stop-shop naturally led to the expansion of its service portfolio, with a focus on the Medicinal Cannabis industry, with specific know-how, creation of new services and acquisition of new one's equipment, and expansion of facilities, as well as the implementation of demanding security measures applicable in this area.
To respond to the regulatory requirements applicable to medicinal cannabis, the LEF has the authorization to:
Manufacturing authorization (GMP part I) of medicines, preparations, and substances based on the Cannabis plant, for medicinal use, in the context of quality control and batch certification
Manufacturing authorization (GMP part II) for the active substance dry flower Cannabis sativa, within the framework of physical/chemical and microbiological quality control
Authorization for the supply for specific purposes of cannabis plant derivatives
Our offer for the Medicinal Cannabis industry includes:
• Quality consultancy in the preparation of documentation for obtaining cultivation and/or manufacturing licenses
• Conception and design of facility layouts
• Training, auditing, and support in qualification and validation activities
• Analytical services, including:
Development and validation of analytical methods
Quality control for the release of medicinal cannabis (Dry flower and extracts)
Stability studies
Cannabinoid's profile
Terpene's profile
Residual solvents
Monitoring of irrigation water quality
Purified water sampling and analysis
Testing of heavy metals in soil, organic and inorganic substrates
Environmental monitoring tests in production areas
• Galenic development of liquid, semi-solid and solid formulations and production of pilot-scale experimental batches
• Preparation of the technical documentation required to submit the application for Marketing Authorization (AIM | ACM) for Cannabis herbal medicines, preparations, or substances
• Preparation of the pharmacovigilance system for Cannabis Herbal Medicines, Preparations, and Substances
