2020-08-04T13:41:29+00:00December 27th, 2018|

An active ingredient is a chemical that is usually a small molecule produced in chemical synthesis processes, while a biological drug is based on components and processes derived from animal or fermentation and/or tumor microorganisms/cells.

1. Molecular weight: Biological drugs, such as peptides and proteins, are huge molecules compared to chemical drug molecule sizes.

2. 3D Structure: Proteins, unlike chemical drugs, have a 3D structure that affects their function.

3. Manufacturing process: The production process of a chemical drug is synthesized for specific molecules in a known process. The biological drug production process, on the other hand, is much more complex and may result in high variability of the final product.

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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