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 for active substances (dry Cannabis Sativa flower) within the scope of physical/chemical and microbiological quality control;
• Supply for specific purposes of narcotic and psychotropic substances and their preparations, including derivatives of the Cannabis plant in the context of development and manufacture of experimental batches on a pilot scale and carrying out studies.
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