Cynthia Ipach, President of Compliance Insight, Inc., founded the company in 2000 with the goal of offering hands-on Quality Assurance (QA) and Regulatory Affairs (RA) services to the Pharmaceutical and Medical Device industries.
A year later co-owner and Vice President, Troy Fugate, joined the company. Since that time, Compliance Insight has grown to include Compliance Specialists in these industries as well as Biotechnology, Foods, Cosmetics, and Dietary Supplements.
The Top 7 Trademarks of Compliance Insight Specialists
- Each consultant has 10+ years “in the trenches” experience within FDA regulated industries – we require people to have hands-on experience dealing with the issues
- They have the ability to get around the “politics,” “chatter,” and “roadblocks” that typically impede a quick response to an FDA issue or resolving compliance problems
- Our specialists work with the client offering workable options that are compliant with required remediation
- The specialists are looking beyond the observation to other systems and making the entire program compliant with GMPs
- Taking into consideration that the firm needs to be operational as well as compliant, we work diligently to bring systems into compliance quickly and efficiently
- Capacity to speak to all levels of the firm – from the CEO to the mechanic – regarding GMP requirements
- Field experience to institute procedures company-wide that are compliant, functional and “really work” as opposed to theoretical fixes that look good but cause issues elsewhere in the company