“Like everyone, I also thought that cannabis was a kind of gimmick. And ten years ago I made no distinction between medical cannabis and cannabis for other purposes,” says Dr. Sigalit Ariely-Portnoy, CEO and founder of the Gsap company.
“Six years ago, for the first time a client came to me who had developed medical equipment for cannabis inhalation. and I told him I didn’t know how to guide him into the marketplace in absence of regulations. So we parted as friends.
"Two years later, it was the experts at Gsap who guided him in achieving IMC-GMP approval and in drawing conclusions from clinical tests of medical cannabis. Since then, the company has dealt with further clinical tests of medical cannabis and its components. We understand that there are many benefits for patients and therefore we must help the companies understand exactly what indications those benefits are associated with and we must ensure the safety of the product for the patients.”
“From the dawn of recorded human history, cannabis has evinced innumerable anecdotal evidence of its clinical effects. Now that the heavy specter of addiction to cannabis has been dispelled in most countries, the belief is taking hold that the cannabis plant is indeed potentially a fountainhead of wide-ranging treatments and medications.
"Researchers in Israel are leading the progress of research and science, including the isolation, characterization, and improvement of components, the development of new products, research into the possible operational mechanisms and possible synergies of the components, understanding of the medicinal effect on various diseases, and possibly the need to adjust the specific treatment to the patient (in the spirit of personalized medicine).
"To all this, in recent years the Medical Cannabis Unit has allied itself, advancing regulations and procedures that will define the requirements for the medical cannabis sector. In the field of regulation too, we are a ‘light unto the nations’ as in practice we relate to medical cannabis production like any other pharmaceutical production in every way. Our team, working with companies in Israel and around the world, is very proud to see how far we’ve advanced in the sector as compared with other countries.”
Being Israel’s leading company for regulatory, clinical, quality, and validation services to pharmaceutical and medical-equipment companies, Gasp made its way into the Israeli cannabis sector as early as 6 years ago. Experts who work at the company include engineers, scientists, clinicians, and quality and regulatory experts, and they have guided more than 20 medical cannabis companies through the following processes:
♦ Planning, advising on construction, and validating cannabis facilities, in Israel and elsewhere, that produce packaged inflorescences, oils, tablets, capsules, creams, suppositories, and inhalers.
♦ Establishing a quality system and laboratories for cannabis facilities, and guidance for Israeli IMC-GMP inspections and European GMP inspections.
♦ Preparing regulatory strategies for submitting products on the pharmaceutical or medical-device track to the FDA and to the European authorities.
♦ Pre-IND and IND submissions on the pharmaceutical track (chemical and botanical medications) to the FDA.
♦ Pre-submission or 510(K) submission to the FDA for medical devices,, and submission of medical devices to notified bodies in Europe.
Management of clinical trials (CRO) for medical cannabis (inflorescences) or for cannabis-based medications and medical devices, including planning the trials, preparing the documents, and submitting to the Medical Cannabis Unit, the Helsinki Committee, and the Ministry of Health.”
“Today in Israel, Gsap has the most experience in the areas we mentioned, and it is helping many entrepreneurs and companies in the sector to rapidly bring value to their investors. We bring to bear, in the cannabis sector, our wealth of experience from the pharmaceutical industry and from medical devices, with adjustments as appropriate.
"Over the years we have seen that our strengths show themselves in how we guide the clients and how we solve complex problems for them. We don’t want to be everyday consultants; we want to lead a significant process that the client alone would be unable to lead, or to give the client knowledge that the system doesn’t make available.”
“I expect enormous expansion in the medical cannabis sector, with focused solutions found for the patients. Even the pharmaceutical companies have started to identify the potential, and they are concentrating on channels of investment or on independent development work. On the basis of experience, I have faith that Israeli innovativeness will produce new patents for us in the sector.”