Análisis de riesgos

The results of scientific studies, together with the openness of the governments of different countries to the legalization of the consumption of medical cannabis and its derivatives, have motivated an important boom in the development of this new industry regulated by very specific requirements crucial for its correct consolidation.

Qualipharma provides the required support at each phase of Medical Cannabis projects. With successful cases at national and international levels, we count on our experienced professionals to cover the critical areas of this industry in order to ensure compliance with the regulations required by each country.

Our customized solutions include the achievement of the following stages:

Support for crop authorizations by the Health Authorities and Regulatory Bodies

  • Legal
  • Commercial
  • Pre-project: varieties, facilities
  • Preparation of Dossier for Authorization Request

Analytical Support

  • Analytical Specifications
  • Analytical Methods Development and/ or Validation of Analytical Methods
  • Stabilities Studies

Botanical Support

  • Characterization of the variety and chemotype
  • Specifications of starting plant material

Support in Facility Design

  • Security system
  • Cultivation:
    • Mothers area
    • Areas of clones
    • Cultivation zones: vegetative phase and flowering
  • Process Areas:
    • Pre-trimming and Trimming Zone
    • Drying area
    • Extraction zone
    • Conditioning area
    • Storage area

Support for GACP and GMP Quality Systems implementation and certification

  • GACP Quality System Implementation
  • Support with Certification Bodies for GACP System Quality
  • GMP Quality System Implementation
  • Support with GMP Certification Authorities
  • Specialized and Customizes Training Programs
  • Technical Direction Responsibilities