Golden, Colorado-December 12th, 2018-Vitro Diagnostics, Inc. (OTCPK: VODG), dba Vitro Biopharma (“Vitro”) one of the world’s emerging biotechnology companies focused on Umbilical Cord Mesenchymal Stem Cell (“MSC”) research and clinical products has been awarded Certification to the International Organization for Standardization (ISO) Quality Standard 9001:2015.
This is a key milestone in the Company’s development as a supplier of advanced stem cell therapies worldwide. The ISO quality standard ranks the company in the top 1% of manufacturers with regards to commitment to customer satisfaction using controlled systems of product manufacturing and service, quality control, distribution, and planning in compliance with all applicable regulatory and ISO standards while engaging in continual improvement based on ongoing performance metrics. The registered quality umbrella of ISO9001 extends to all operations of Vitro Biopharma.
Dr Jim Musick, CEO & CSO said, “We are very pleased to receive Certification to the ISO 9001:2015 Standard. This is an important milestone in our regulatory compliance program to assure continual supply of high-quality stem cells and related products and services for clinical applications worldwide. This certifies Vitro as an ISO 9001 manufacturer and service provider that is cGMP compliant and CLIA registered. Our world class certifications support our continued international growth accelerating our IRB approvals into clinical stem cell trials. Together our stem cell manufacturing and diagnostic services provide a comprehensive platform to fully support clinical regenerative medicine studies. Our regulatory team, including our QA Director our COO and our FDA Advisory team were instrumental in the development and implementation of all tasks necessary to achieve the ISO Certification during 2018.”
Vitro Biopharma, for over 10 years, has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with it’s Umbilical Cord Mesenchymal Stem Cells, it’s MSC-Grow™ Brand of cell culture media and diagnostic services.
We now support clinical studies of stem cell therapies for osteoarthritis, neurodegenerative diseases including Parkinson’s disease, Multiple Sclerosis and Alzheimer’s disease while also pursuing select US markets for stem cell therapies. Our overall objectives are to support high quality offshore medical tourism with DaVinci Wellness Centre, our clinical trial partner in the Cayman Islands.
In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with over 10 years’ experience in the development and commercialization of stem cell products for research and clinical use recognized by a Best in Practice Technology Innovation Leadership award for
Stem Cell Tools and Technology and a growing track record of successful translation to clinical therapies. We plan to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and over time, gain regulatory approvals in the US.
ABOUT THE INTERNATIONAL ORIGANIZATION for STANDARDIZATION (ISO)
The International Organization for Standardization (ISO) (www.iso.org) is the world’s largest developer and publisher of International Standards. It is comprised of national standards bodies from 159 countries that promote high quality standards for all company processes. To meet ISO 9001 certification requirements for Quality Management Systems, companies must establish a well-tuned system of interacting processes that ensures consistent quality of the company’s products; their capacity to optimally meet customer requirements; and their fulfillment of all applicable regulatory requirements.
Vitro BioPharma ISO 9001; cGMP; CLIA registered clean room laboratory in Golden Colorado.
Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company’s auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements”. Such forward looking statements are identified by words such as “intends,” “anticipates,” “believes,” “expects” and “hopes” and include, without limitation, statements regarding the Company’s plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company’s products in the market place,
general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company’s filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.
Dr. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 3
Source: Vitro Diagnostics, Inc.