2020-08-04T13:48:05+00:00December 27th, 2018|

The drug development process is a lengthy process, and one of the longest, most expensive and significant stages is the clinical phase, whose purpose is to show that the drug is safe to use and effective. The first phase of clinical studies (Phase 1) is the first human study, and comes after laboratory and animal studies (preclinical). The second phase (Phase 2) is the phase in which the drug’s effectiveness in humans begins to be tested. Phase 3 is the last step before submitting the product for regulatory approval. Phase 3 is the most valuable and significant stage because testings is being done on a larger population and in multiple locations. Phase 4 (post-market) studies deal with collection of clinical data after marketing the drug, in order to complete and process information about the drug’s safety and  efficacy.

To the article Drug development and FDA registration from preclinical to clinical trial, validation and GMP

Product Development, Delivery System & Clinical Trials

Novel cannabis products and delivery system for improved bio-availability, accuracy, consistency and efficacy that can be proven and backed up with a strong IP and clinical trials

Growing, Manufacturing & Lab Facilities Design

Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices

Quality Assurance & Good Practices (GxP)

An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training

Cultivation & Product Manufacturing Technology

Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.

New Product Regulations & Submissions

Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets

Qualification &Validation

New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports

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