Regulation and Quality Control Services for Medicinal Cannabis
Regulation and quality control for medicinal cannabis are among the most complex in the healthcare industry.
It is a highly regulated sector, with rigorous requirements involving cultivation, manufacturing, distribution, safety, traceability, and continuous monitoring, varying significantly between jurisdictions.
ELS Group acts as a strategic technical partner in regulatory and quality management services for medicinal cannabis, supporting companies at all stages of the chain, from cultivation to market placement, with integrated operations in Europe and Latin America.
With a presence in 11 countries and pioneering experience in the sector, including participation in the first registration of medicinal cannabis in Portugal, ELS Group structures regulatory and quality solutions that allow for predictable, safe, and sustainable operation in highly regulated markets.
ELS Group's Complete Scope of Regulation and Quality Control for Medicinal Cannabis
ELS Group’s work in regulation and quality control for medicinal cannabis covers the entire regulatory cycle of the activity, from cultivation to manufacturing, wholesale, product regulation and post-market, always aligned with the requirements of the competent authorities.
Our work includes, in an integrated and personalized way, the following services:
Licensing of activities at Infarmed (cultivation, manufacturing, import and export, wholesale trade)
- Application for a License for the activities
- Monitoring the licensing process at Infarmed.
- INFARMED Inspection Scheduling
- Scheduling a PSP Inspection
Pharmaceutical Engineering
- Functional layout design of the facilities.
- Development and/or validation of the layout for the facilities.
- Design of the cultivation, manufacturing, or wholesale process at the facilities.
- Supplier selection and qualification
- Monitoring the construction of facilities and assembly of equipment.
- Selection and qualification of appropriate human resources.
- Installation startup
- Operational management and safety measures
We strategically develop and analyze the entire licensing project for the cultivation, manufacture, or distribution of medicinal cannabis. We build and support the development of the project from the ground up, from choosing the most suitable location and implementing the project to final licensing, complying with INFARMED requirements in GACP (Good Agricultural and Harvesting Practices), GMP (Good Manufacturing Practices), and GDP (Good Distribution Practices).
ELS Solutions can offer your company guidance in cultivation/manufacturing processes from seed/clone to the sale of the final product, becoming an extension of your team through all the necessary steps in launching your product.
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Frequently asked questions about the regulation and quality control of medicinal cannabis.
What does regulation and quality control for medicinal cannabis involve?
Regulation and quality control for medicinal cannabis encompass the set of legal, technical, and operational requirements that allow for the safe and compliant cultivation, manufacture, distribution, and marketing of cannabis-based products.
This includes specific licenses, quality systems, audits, surveillance, and ongoing maintenance of regulatory compliance.
When does a company need to structure regulation and quality control for medicinal cannabis?
From the initial stages of the project, the definition of the regulatory framework, applicable licenses, and quality systems must occur before the start of operations and remain active throughout the entire business lifecycle, including cultivation, manufacturing, wholesale, product regulation, and post-market activities.
What licenses are required to work with medicinal cannabis?
Licenses vary depending on the activity and the country, and may include GACP authorizations for cultivation, GMP for manufacturing, GDP for distribution, wholesale trade licenses, import and export licenses, as well as specific authorizations for placing or introducing products to the market. Each step requires specific regulatory assessment.
Does regulation end after obtaining the initial licenses?
No. Regulatory compliance is ongoing. After obtaining licenses and authorizations, companies remain subject to audits, inspections, surveillance, renewals, post-registration changes, and regulatory updates. Maintaining compliance is essential for business continuity.
In which countries does the ELS Group operate?
ELS Group operates internationally, with a presence in 11 countries, offering regulatory and quality support in Europe and Latin America.
The company has specialized local teams that work in an integrated manner with the main regulatory authorities in each region, allowing it to align global strategies with the specific regulatory requirements of each market.