ELSAcan
MEDICINAL CANNABIS
From February 2019, INFARMED I.P, the Portuguese Medicines Regulatory Agency, approved the use of Cannabis for seven therapeutic and medicinal purposes.
Following these legal and policy changes in the use of Cannabis in Portugal and the rest of Europe, ELS Solutions has been active in this market in a variety of ways, including:
- Development of a business plan customized to the client’ s characteristics and objectives;
- Cultivation and production planning;
- Preparation and submission of licensing file;
- GMP Certification;
- Obtaining the license for seed cultivation, importation and exportation;
- Prospecting, Qualification and active management of international distributors and buyers.
In addition to the active participation in these issues in Portugal, ELS Solutions has also participated in ANVISA's discussion of Public Consultations published in Brazil, contributing to Portugal's regulatory model for initiating the regulation of Cannabis for medicinal purposes in Brazil.
ELS Solutions can offer your company seed-to-sale guidance by becoming an extension of your team, through all the necessary steps on launching your product, from:
- Business planning;
- Cultivation and production planning;
- Land prospection;
- Regulatory clearance and licensing;
- Engineering;
- Quality control and assurance;
- Technical direction;
- Extraction and oil production advisory;
- Business intermediation with international customers;
- Post-license quality assurance.
ELS Solutions is the partner of choice into all steps including but not limited to:
- Regulatory setup and dossier clearance;
- ACM and AIM INFARMED authorizations;
- EU-GMP certification including all needed steps;
- Layout, design, engineering and production planning including site master;
- Analytical testing;
- Batch release;
- Pharmaceutical packaging;
- Pharmacovigilance compliance;
- Audit Management and assistance;
- Regulatory and administrative clearance at municipality level.
