2020-08-04T11:53:07+00:00December 23rd, 2018|

Cosmetic products that do not contain color additives, or other materials that require approval for use, do not require FDA approval prior to marketing.
In contrast, cosmetic products that belong to the over-the-counter (OTC) category require listing of the drug product(s) and drug substance(s)/active ingredient(s) that are added to the cosmetic products. Cosmetic manufacturers and packaging companies (outside the US) who want to export their products to the US are committed to registering their foreign establishments, factories and manufacturing facilities.

To the article “Regulations and Registration for Cosmetics, Cosmetics and OTC Products”

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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