TEDOR expects to gain operational efficiencies for future growth using AssurX platform.
Morgan Hill, CA., June 19, 2019 – AssurX, Inc. , a leader in enterprise quality management software today announced that oral solid dose contract development and manufacturing organization (“CDMO”) TEDOR Pharma Inc. has selected the AssurX platform to fully automate their quality and compliance management processes. TEDOR will use a combined solution of document, training and audit management, change control, supplier quality, CAPA, quality events, deviations, and lab investigations to bring further consistency, accessibility, and efficiencies to their business..
“We are a fast-growing company and our systems need to be ahead of our growth,” said David Vario, Vice President of Quality and Regulatory Affairs at TEDOR. “By having these processes automated and connected, we can be more efficient and compliant in our quality system activities.”
Since the AssurX platform gives customers the flexibility to also develop their own processes, Vario plans to build a preventive maintenance calibration process to provide a break/fix audit for all equipment within their facilities.
“We are delighted to partner with Adial to provide CDMO services for AD04,” commented Doug Drysdale, President and CEO of Tedor Pharma. “AD04 can be easily and efficiently manufactured at large scale to the U.S. Food and Drug Administration and the European Medicines Agency standards, with high consistency and a long-expected shelf life, which make it well suited for both the clinical trials and mass commercialization.”
“TEDOR Pharma is using the built-in, core strengths of our product and then extending its use to meet other business requirements. This is made possible because the AssurX platform is intuitive to both developers and non-developers alike. It’s what the company was founded on and what we continue to give our customers as our product evolves,” said Tamar June, AssurX President and CEO.
Vario says that having all the processes in one central system will provide additional benefits to TEDOR’s customers with Annual Product Reviews (APR) that can be prepared quickly. “Our customers have to provide the FDA and other regulatory agencies with a yearly review and with a click of a few buttons, we can now generate the manufacturing portion of APR for them since all the information will be in the AssurX platform.”
A full list of AssurX software and industry solutions can be found here.
ABOUT ASSURX INC.
With decades of expertise built into our quality management and regulatory compliance software, the AssurX Quality Management Software Platform helps companies maintain quality and compliance standards, streamline workflow and better manage any enterprise. Our configurable software and understanding of users’ needs produce a unique system that easily adapts as a customer’s business evolves. AssurX is an ideal partner for regulated companies looking for better operational control and efficiency while staying compliant. To learn more, visit: www.assurx.com.
ABOUT TEDOR PHARMA, INC.
Tedor Pharma is a specialized Contract Development and Manufacturing Organization (“CDMO”) with a strong track record of success in developing and manufacturing solid dose products, including DEA-scheduled products, for life science customers. Over the past 18 years, TEDOR has helped customers meet their project timelines, achieve regulatory approvals and solve many formulation challenges from development through to large-scale manufacturing.
For more information: www.tedorpharma.com