Cynthia A. Ipach, President & CEO
Compliance Insight, Inc. helps businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for the manufacture of innovative drugs, medical devices, and biologics. “For many years, we have been working with the FDA and industry thought leaders on the most important issues that the life sciences industry is facing. This enables us to be involved in helping set precedence for new regulations with the FDA and share the latest FDA expectations with our clients,” says Cynthia A. Ipach, the President and CEO of Compliance Insight, Inc.
Since the inception of the Food and Drug Administration (FDA)in 1906, the U.S. has been focused on protecting the public health by controlling and supervising several products from the life sciences industry. To ensure that these products are safe and effective, the FDA has passed numerous device and drug regulations that continue to become more stringent over time. Even though these rules are required to protect the public, it has become a hurdle for pharmaceutical companies to provide new solutions that better meet the changing needs of their customers— especially when it comes to product commercialization. This task became even more complicated when the FDA introduced its new division, Office of Pharmaceutical Quality (OPQ), to create a uniform drug quality program across all manufacturing sites.
Leveraging her years of experience and expertise, Cynthia understands that industry practices are always rapidly evolving. As such, she has found compliance to be more challenging in several environments. One example of a challenging environment that Compliance Insight has prepared to simplify for their clients would be AI implementation in the manufacturing space.
For many years, we have been working with the FDA and industry thought leaders on the most important issues that the life sciences industry is facing
This represents a monumental breakthrough that many companies will struggle with due to the lack of holistic planning and sound strategies necessary to meet the objectives of the larger picture as well as inability to monitor, analyze and act on massive amounts of data. Compliance Insight can provide proper governance to help overcome the major hurdles causing waste of both time and resources.
With a comprehensive understanding of these factors, Compliance Insight is leading a collaborative effort with Xavier Health, Cincinnati, Ohio to generate a Roadmap for AI implementation. This will involve industry thought leaders and the FDA working together to develop case studies, a maturity model, and risk analysis to create a basic roadmap for implementing AI in the manufacturing environment in a systematic manner. Additionally, the company will offer a Quality Culture Improvement Program (QCIP) platform to help clients identify product quality risk metrics linked to patient safety that can be discovered during an inspection.
Another exciting trend will be the use of scientific information from free science sharing platforms. “Compliance Insight has already participated in one such open science collaboration platform, The Knowbella Platform from Knowbella Tech,” says Cynthia. It is a scientific collaboration ecosystem that puts scientists at the center of research and provides rewards for participating in collaborative research. The platform also provides access to Good Manufacturing Practices guidance and consulting, as well as grants communication tools, manuscript development tools, and more. “This helps scientists not only come up with discoveries but make them palatable to other companies and regulators,” Cynthia comments.
In a nutshell, by listening to its clients and fully comprehending their needs, the company provides the optimal solution to help the life sciences industry introduce best-in-class products in the market. “With our unique service offering that never lets a client cross the line set by the FDA, and steady focus on the changes that are yet to come, we have grown into a one-stop-shop for diverse compliance needs,” Cynthia concludes.