Cannabis

In many countries in the world, including in Israel, cannabis has been used for medical purposes, especially for the relief of symptoms in many diseases. In the recent years there has been significant scientific research progress in the field of cannabis in isolation, characterization, and improvement of the active ingredients. The number of clinical studies on the subject are increasing in the quest for the clinical establishment of the plant (and its components) not only to alleviate symptoms but also as a therapeutic agent.

 

Gsap applies its extensive pharmaceutical experience to the field of medical cannabis while making the relevant adjustments.

To date, Gsap is involved in > 25 cannabis projects of Israeli and overseas companies. This includes: (a) the establishment and certification of manufacturing facilities, wholesalers, and laboratories - newly built or modified existing building (b) advanced development of pharmaceuticals and medical devices and (c) management of clinical studies. Gsap is well familiar with the IMC-GMP and IMC-GDP standards, and has an on-going fruitful dialogue with key opinion leaders in the field and with the Ministry of Health and the YAKAR.

 

A growing number of countries worldwide have lifted the regulatory restrictions on cannabis thus enabling researchers to study the medicinal properties of cannabis and improve its therapeutic effects.

In Israel – a world leader in the cannabis field – a cannabis dedicated unit operates in the MOH, called the Medical Cannabis Unit (the YAKAR). In the recent years, the YAKAR has been implementing the process of Medicalization of cannabis in order to establish appropriate standards in cannabis for medical use and research. The medical cannabis industry is essentially based on production of validated processes providing quality medical grade cannabis products, In line with the pharmaceutical industry good manufacturing practices (GMP).

Every component in the supply chain of cannabis products must meet the highest quality standards, in accordance with IMC-GAP, IMC-GMP, IMC-GDP, and IMC-GSP standards corresponding to: growth, manufacturing, distribution, and security processes accompanying them.

Several medical cannabis products are already marketed at Israeli pharmacies. In addition, in view of the economic potential of exports it is anticipated that in the near future the recommendations of the inter-ministerial government team will be adopted to approve the export of medical cannabis.

Gsap accompanies the customers from product development through pre-clinical and clinical studies, development of the production process and establishment of facilities.

The following is a list of our services:

For those entering the field (developers and manufacturers):

  • Writing Form 1 (initial approval to engage in the field) and submitting it to the YAKAR.

For facility establishers:

  • Design production processes and production lines for the products and outputs defined by the customer.
  • Gap analysis for newly built or converged facilities
  • Writing a user requirements document (URS) for production facility, product quality testing laboratory, wholesaler.
  • Writing the URS for the main manufacturing machines
  • Preparation of the project total indicative budget.
  • Conceptual design.
  • Submission of the plans to the MOH for its approval.
  • Review of the detailed design
  • Supervision (GMP aspects) during construction.
  • Writing SOPs according to GMP and adjusted to the costumer's team, spanning: quality assurance, quality control, production process, environmental monitoring, storage, facility maintenance and its infrastructure, facility cleaning operation and equipment maintenance.
  • Establishing and implementing of the GMP quality system, including staff and quality management training.
  • Validation (protocols, executing/inspection, reports) of: facility infrastructure, production equipment, production processes.
  • Writing required internal laboratory SOP.
  • Writing protocols of test methods and their validation
  • Writing protocols for stability
  • Accompanying communication with external laboratories (for tests that will not be performed in-house).
  • Accompanying the Ministry of Health's approval examination until final approval and receipt of IMC-GMP certification.
  • Continued support after the launch of the plant.

For drug developers:

  • Preparation of comprehensive regulatory strategy from the development stage, through pre-clinical stage to clinical trials.
  • Presentation of the sponsor and plans to the Ministry of Health.
  • Assistance in importing inflorescences or cannabis products for developmental needs.
  • Connecting cannabis manufacturers and related service laboratories.
  • Consultation and accompaniment along the innovative development.
  • Pre-clinical consulting and guidance.
  • Writing documents (investigator brochure, protocol, consent forms) and submitting them to the Ethics Committees and the Ministry of Health.
  • Writing submission documents and submitting them to regulatory authorities abroad (FDA, Europe, other countries).
  • Full CRO services – clinical trial management, hospital monitoring and data management.