HAYWARD, Calif.--(BUSINESS WIRE)--Pharmatech Associates, a compliance consulting firm serving companies in the pharmaceutical, biotech and medical device industries, was instrumental in helping Intelliject and it’s manufacturing suppliers prepare for and pass all of the FDA pre-approval inspections associated with its New Drug Application for an innovative epinephrine auto-injector, e-cue™.
Because of their detailed understanding of quality systems and compliance requirements, Pharmatech Associates was engaged by Intelliject to assist in getting itself and its manufacturing suppliers prepared for their FDA pre-approval inspections. “Pharmatech Associates played an integral part in ensuring that Intelliject and our suppliers passed our pre-approval inspections. We counted on their attention to detail, their ability to execute and remain on schedule. Moreover, their depth of understanding with these tasks gave a strategic capability that has added tremendous value,” said Mark Licata, Intelliject’s VP Industrialization and Quality.
“For innovative products such as Intelliject’s e-cue that require thoughtful integration of multiple technologies, diverse regulatory and compliance philosophies and deep process and automation expertise, we have some of the best experience and know-how in the industry,” said Gregg Ekberg, COO of Pharmatech Associates. “As a global leader in compliance, we can help pharmaceutical and device manufacturers meet their design and regulatory requirements quickly and effectively, and enable them to bring new delivery platforms and therapies to patients safely without delay.”
About Pharmatech Associates
Pharmatech Associates, Inc. (founded in 1995) consults to the pharmaceutical, biotech, medical device manufacturing and other regulated life sciences industries. Headquartered in the San Francisco Bay Area, Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in North America, Asia, and Europe. Please visit: www.pharmatechassociates.com