Services for Medical Cannabis
Obtaining GACP License - Cultivation of Cannabis Plant for Medicinal Purposes
Obtaining Import and Export License for Medicines, Preparations, and Substances based on Cannabis Plant for Medicinal Purposes
Obtaining GMP I License - Manufacturing of Medicines, Preparations and Substances based on Cannabis Plant for Medicinal, Veterinary, or Scientific Research Purposes
Obtaining GMP II License - Manufacturing of Medicines, Preparations and Substances based on Cannabis Plant for Medicinal, Veterinary, or Scientific Research Purposes
Obtaining GDP License
Obtaining Wholesale Trade License for Medicines, Preparations and Substances based on Cannabis Plant for Medicinal Purposes
Regularization of Cannabis Products - Preparation, review, and submission of the necessary technical dossier for the regularization of Cannabis Products with the local regulatory agency
Obtaining Market Placement Authorization (MPA) for Preparations and Substances based on Cannabis Plant for Medicinal Purposes
Obtaining Market Introduction Authorization (MIA) for Medicines based on Cannabis Plant for Medicinal Purposes
Post registration Services (Hosting services - Local Representation for Cannabis) - Legal Representative, Pharmacovigilance, and Technical Representation Qualified Person (QP) Services
Risk Classification Analysis - Determining the correct classification of Cannabis products according to the local regulatory agency
Compliance Assessment
Good Laboratory Practice (GLP) Audits
GACP Audits
Functional Layout Design of the Production Unit
Issuance of Health Licenses/Authorizations
Development of Business Plan for cultivation, manufacturing, and wholesale trade of Cannabis
Security Measures Development
Consultation on the selection and formulation of hybrids, seeds, and clones
Establishment of Quality Management System (QMS) procedures and operations
Preparation of regulatory advices
Registration Renewal
Post-Registration Changes
Training
Regulatory-Strategic Support
Documentation Gap Analysis
Feasibility Report Preparation for Cannabis product regularization
Assistance in drafting responses to notifications and sanitary infractions
other services
Regulatory & Quality
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Distribution Headhunting
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Import
ELS Solutions provides a robust Import, Warehousing, Billing and Customer Service service, in the countries where it is represented, so that the customer controls their business, their margin and does not need to depend on the distributor, focusing on increasing of sales.
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