Medical Cannabis

    Medical Cannabis

    The constantly evolving medical Cannabis field poses challenges due to the local regulatory status and differing requirements in each country. By keeping up-to date with these changes and through its breadth of services, Gsap supports and accelerates tens of development projects worldwide, spanning: establishment of Cannabis processing and manufacturing facilities, development of Cannabis based therapeutics and medical devices, and clinical trials of Cannabis-based products.

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    Regulatory

    Gsap provides companies with a regulatory strategy to accelerate approval of their facilities and clinical trial protocols, to decrease time to market. Gsap also prepares the documentation for submission to the regulatory authorities and leads discussions with the authorities regarding the essential requirements for Cannabis-derived products.

    Our regulatory services include:

    ●Submission of Cannabis products in Europe:

    In general and Germany in particular which is the most advanced among European countries. Generally, there is not a single route for Medical Cannabis approval across Europe thus, each EU country needs to be addressed according to its own regulations regarding Cannabis.

    ●Source of Product type:

     The source of the medicinal product may be synthetic or herbal;

    1.A non-herbal source medicinal product route (e.g. synthetic origin) is a regular medicinal product route, manufactured in the pharmaceutical factories (such as paracetamol), and requires all tests to be approved (Clinical and Preclinical Trials).

    2.Herbal-based medicinal product (similar to Sativex®): a medicinal product containing one or more active substances from a plant source or an herbal preparation or a combination of the two. Data should be presented that the herbal material has well-established pharmaceutical use, with over 15 years in the European community, a recognized efficacy and acceptable level of safety. In addition, it is necessary to demonstrate quality and consistency of the drug manufactured in order to ensure that the patient receives the same product every time and is free of contaminants. The competent authorities are entitled to request, where necessary, the data for: safety assessment, quality aspects of the medicinal product, the product must be analyzed for physical\chemical, biological and microbiological tests and to comply with the relevant quality standards in Europe: Pharmacopeial monograph, HPMC guidelines and relevant directives (2004/24 / EC & 2001/83 / EC).

    ●Obtaining a permit to import Medical Cannabis into Germany:

    Germany only imports medical Cannabis from farms and facilities operating under the 1961 Convention of Narcotic Drugs. In order to import Medical Cannabis to Germany, an EU-GMP certificate from the EU member state is required. Manufacturers wishing to distribute Medical Cannabis products in Germany must be in agreement with, or be the owner of a domestic importer.

    ●Medical Cannabis Product Specifications:

    Similarly, to medicinal products, test methods and specifications have been defined in some countries. The set

    of methods and specifications for raw material or medicinal is defined as a monograph. In several countries where medical Cannabis products were approved, such as in the Netherlands and in Germany,

    local monographs for medical Cannabis were defined.

    ●Facility associated regulatory aspects (e.g. the extent of required GMP in the post-harvest) :

    The GMP requirements for Post-Harvest in Europe Medical cannabis manufacturers aiming to sell their products in Europe and specifically in the German market must meet two main requirements:

    (1) compliance with the Herbal Medicinal Products Committee (HPMC) requirements of the European Medicines Agency (EMEA) and Good Agricultural and Collection Practice (GACP) Guidelines for Plant-Derived Starting Materials

    (2) compliance with European GMP (EU-GMP) requirements, EudraLex – Volume 4 – Annex 7, Manufacture of Herbal Medicinal Products.

    Annex 7 (to EU GMP) presents the requirements for facility, equipment, documentation and process control for production of herbal products.

    quality assurance medical

    Quality (QMS)

    Top quality is of paramount importance and crucial for successful marketing. Quality embraces every aspect of a company’s facilities and activities. Gsap not only writes SOPs but, rather, implements a culture for quality.

    A Quality Management System (QMS) compliant with the regulatory requirements is developed together with the client to ensure its suitability for each particular organization and product.

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    Clinical

    The clinical stage in the development of an investigational product is intensive, demanding and requires many resources. Gsap provides end-to-end services from study planning, through execution during the clinical life cycle of your cannabinoid-based product. Clinical studies are necessary for the development and approval of medical products.

    Clinical studies are necessary for the development and approval of medical products.

    Cannabis-based medical products require clinical trials and submission of detailed clinical study reports for registration/marketing authorization by the authorities. The study design is a key factor and must take into consideration the study population, intervention type, control group, response variables, measures to reduce bias, statistical analysis and so on. An appropriate clinical plan and trial execution will enable deep understanding of your product’s performance and its effect on humans.

    Our clinical services include:

    Study planning and set up

    ●Study start up, documents preparation e.g. Clinical Protocol, Investigator Brochure, Informed Consent Form

    ●Study feasibility and sites selection

    ●Regulatory submissions and contracts

    ●Site management and clinical monitoring

    ●Data management and biostatistics

    ●Project management

    ●Interim and final study reports

    Engineering and Validation

    Gsap implements GEP (Good Engineering Practices) within its project management methodology in order to perfectly comply with EU-GMP standards and regulations and provide its clients cost-effective solutions Services.

    Our engineering services include:

    GMP consultation

    ● Facility User Requirement Specification (URS) and conceptual design

    ●Validation Master Plan (VMP)

    ●processes and cleaning validation

    ●validation of equipment and infrastructure

    pre clinical studies

    Pre-clinical

    Gsap provides Preclinical consultation for in-vitro and in-vivo studies to define the pharmacological and toxicological effects of investigational pharmaceutical products including cannabinoid-based drugs, if required. These studies are performed prior to initiation of early-phase clinical trials.

    There is no single uniform approach to design a preclinical program for all investigational products. Studies must be tailored according to the type of investigational product, and the proposed clinical trial in consideration of the respective guidelines or standards.

    Our pre – clinical services include:

    Preclinical strategy planning

    ●Gap analysis

    ●In-vitro and in-vivo preclinical study design

    Prepare or review preclinical study protocols and reports

    ●Perform systematic literature review and interact with the regulatory authorities

    ●Assist in preclinical CRO selection

    ●Pre-Clinical CRO audit, including design of experiments, writing protocols, reports and supporting the development of analytical and bio-analytical methods.

    FDA audit

    Audits

    Implementation of Good Manufacturing Practice in the medical cannabis industry (IMC-GMP) is from a different point of view and not the same as for the pharmaceutical industry. Specific Good Agriculture and Distribution practices (IMC-GAP, IMC-GDP) are also required. Gsap provides professional, flexible, internal and external auditing solutions. We are your partner for auditing all of your suppliers, subcontractors, or service providers involved in the cannabis product lifecycle

    Our Audits services include:

    Mock inspections with data integrity-conducted by Gsap’s team of former Israeli Ministry of Health (MOH YAKAR) and EU regulators that will help your company prepare for the real inspection

    Good manufacturing practice including: IMC-GAP, IMC-GMP, IMC-GDP compliance audits

    Data integrity audits and assessments

    Audit of cultivation suppliers for Cannabis flowers

    Audit of subcontractors for manufacturing, packaging and analytical laboratories

    Global Submission

    Navigate your product development towards market compliance

    • Europe

      Germany: BfArM

      Netherlands: OMC- Office of Medicinal Cannabis

      ●Submission of Medical Cannabis products in Europe

      ●Obtaining a permit to import Medical Cannabis into Europe

      ●Facility associated regulatory aspects(compliance with HPMC, EU-GMP)

    • Israel

      The Medical Cannabis Unit (YAQAR)