We work in a regulated industry, and sometimes even with the best of intentions things can go terribly wrong. In these cases you may receive findings on an FDA form 483, receive a Warning Letter, or be placed on the Application Integrity (AIP) list. Resolving the issues that precipitated these events requires both an understanding of your business and an understanding of what is important to the agency.

Key Benefits

• We have longevity in the medical device industry and have helped others with these situations.
• We've also managed to extricate companies from regulatory purgatory.
• We can help "before the fact" by performing a gap analysis inspection of your facility so that you can avoid these problems.

Capabilities

It's no fun when the agency comes down hard on a company, and usually there is no easy or fast way out. For example, many AIP listed companies go out of business before resolving their issues. It doesn't have to be this way, and we've had success in helping deficient clients to improve greatly.

Getting Started - Discovery

We spend time understanding the precipitating events and the Agency's reactions.

Correction

We collaborate with you to develop a plan to address the root cause of the events, not just the specifics of the citation. Once the plan is finalized we work with you to implement whatever changes are necessary and provide follow-on monitoring to ensure continued compliance.

Liaison  

We have a long-standing working relationship with the FDA, and can work with you to improve communications.

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Copyright © 2007 NJK & Associates, Inc.
Last modified: 03/19/07