Is global medical cannabis a regulatory compliance business?

Is global medical cannabis a regulatory compliance business?
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For medical and recreational cannabis production, Cannabis OneFive, Inc.’s (C15) solutions fit like a bullseye into a realm of regulatory compliance. Why? Let’s find out.

Besides the obvious elements of genetics, strains, cost of growing/production, supply chains, off-take agreements, white labelling, and other common business operational activities sits the regulators. Two sets, the domestic EU regulator and the export market regulator. The medical cannabis business is first and foremost a regulatory compliance industry with many risks.

How are these risks best managed? Look at the similar industries where many of the regulatory rule sets are derived. People, processes and technology manage these risks. Here we’re going to highlight the role of technology.

First things first: who is C15?

Regulators typically draw on precedents from the pharmaceutical, consumer packaged goods (CPG), food, beverages and even natural health products for legislation. Cannabis OneFive, Inc. is a technology partner for Veeva Systems, Inc. C15 brings the Veeva regulatory and risk compliance platforms from the same sectors the regulators use for precedents.

The world’s largest most successful pharmaceutical, CPG, and largest brand companies use the identical platforms that C15 bring to the cannabis sector.

Let’s talk regulatory compliance

There is a distinction between medical cannabis, recreation cannabis and medical grade or pharmaceutical cannabis. Medical cannabis is not a pharmaceutical molecule or drug. While there are some cannabis derived drugs that have received market authorisation from an applicable regulatory authority, most of the medical cannabis EU export market will strive to be ‘pharma grade’ but will not be a pharma drug, per se.

The risks of non-compliance can include impounded product, product recalls, fines and other penalties, licence suspension or revocation, increased regulatory overview, slow approvals on products and exports, reduced revenue, reputation loss and even a potential out of business sign hanging on your facility. In Canada, many examples exist regarding the costs of not properly managing all of these risks.

Where does C15 fit in all of this?

C15’s solutions, for medical and recreational cannabis production, fit like a bullseye into a realm of regulatory compliance which falls neatly into their flagship product – C15QualityOne Document Control and Quality Management Systems.

Every company should have an end-to-end IT platform, of which QMS is a mission critical part but not the only part. There is no one-stop shop for such an IT risk platform, however, with the selection of an ERP integrated with QMS, gets the user almost all the way to having the painkiller needed to succeed.

To put in simple and stark terms if you aspire to EUGMP status and ‘pharma grade’ medical products then this level of quality is simply not possible to attain and maintain unless you have a Document Control and Quality Management System fully deployed.

The culture of quality

C15 speak of their customers having a culture of quality. This comes down to a focus on GMP ‘type’ practices, especially for medical cannabis, independent governance structure for the quality assurance professionals, and a proper board approved budget for IT solutions.

Cannabis OneFive, Inc. remain the leading choice in the global cannabis sector for unified Document Controls and Quality Management Systems, for a reason: they want their customers to succeed.

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