Rapid Therapeutic Science Files with FDA to Register Facility and Products

DALLAS, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL) an SEC fully-reporting, growth-oriented manufacturing and marketing company focused on employing FDA-approved Metered Dose Inhaler (MDI) technology to deliver aerosolized cannabinoids, such as CBD, CBG, and CBN, announces that it has formally engaged FDA Compliance Solutions, LLC to begin the initial FDA regulatory process of registering their new facilities and ultimately all products. FDA Compliance Solutions, LLC will act as RTSL’s agent through the entire registration process. FDA Compliance Solutions submitted RTSL’s initial filing required by the FDA in May 2020.

This registration process will establish the initial account and fulfill preliminary FDA compliance notification requirements by documenting current domestic manufacturing locations, and product offerings in the secure approved FDA electronic directory database for all products in commercial distribution in the United States.  Registration will incorporate presentation of associated product advertising and labeling (exterior packaging, instructions for use, websites, and promotional materials).

Donal R. Schmidt, Jr., CEO states “We look forward to having our facilities and products fully registered. This will ensure our products adhere to the highest standards of safety and efficacy as required by the FDA for any type of medical product being sold in the US or abroad. Except for our cannabinoids, all our consumables and excipients are already listed in Drug Master Files (DMF) with the FDA. This is the first step in ultimately obtaining a fully compliant product in the anticipated regulatory environment related to cannabinoids.  By seeking registration in conjunction with our new ISO 13485 manufacturing laboratory facility, we are leading the cannabinoid space in the standards that the rest of the medical world utilizes.”

This effort will lay the introductory groundwork for full implementation of cGMP (current Good Manufacturing Practices) operational control.  These regulations have the force of law (Quality System Regulation - 21 CFR 820 - 06/01/97), with the primary intent of ensuring provision of safe, pure, and effective products.  Rapid Therapeutics’ goal of delivering quality products, while safeguarding the health of our many consumers remains the highest priority.