Your Hands-On Quality and Regulatory Specialists

Success!

We would like to share with you some of our success stories so that you can get a better idea of what to expect when we work with you.  Below are a few examples of the kinds of support we provide to FDA-regulated industries.

Case Study 1 -- Warning Letter Resolution

Compliance Insight was contacted by a medical device manufacturing company to help with a warning letter for a number of significant GMP inspectional observations. We took the following steps to help the client establish regulatory compliance:

1. Prepared warning letter response with a time line to complete each observation.
2. Provided periodic status updates to the FDA for the issues stated in the warning letter and notified them of the remedial action taken in each case.
3. Trained all the employees on Quality System Regulations and Good Manufacturing Practices.
4. Established Quality system at all levels of the organization.
5. Prepared and implemented procedures as per Quality System Regulations.
6. Communicated with the FDA on a continual basis to ensure that all pending issues were addressed satisfactorily.

The follow-up inspection by the FDA was a complete success.

Case Study 2 -- Medical Device 510k & Canadian License Applications
 
A foreign manufacturer of Class II in-vitro diagnostic devices, seeking to market their products in the US and Canada, turned to Compliance Insight for assistance.  Working closely with the client’s US agent, we prepared and submitted a number of 510k applications to the FDA as well as license applications to Health Canada.  We took the following approach to enable this manufacturer to legally market their products in the US and Canada:

1. Identified appropriate predicate devices for FDA 510k applications.
2. Obtained and reviewed necessary documentation from the client.
3. Developed protocols for clinical studies needed to demonstrate substantial equivalence to predicate devices per FDA requirements.
4. Helped coordinate, manage and review data from additional clinical studies required by FDA.
5. Prepared and filed submissions to FDA and Health Canada.
6. Provided FDA interface during their review and clearance process.
7. Assisted with device listing requirements.

The client now legally markets a number of in vitro diagnostic devices in the US and Canada. Compliance Insight provides continuing support to the client as new devices are developed.

Case Study 3 --  Training:  ISO to Q7A

The client, a medium size chemical supply company, needed training.  They supplied chemicals to numerous pharmaceutical facilities.  Their global corporation wanted to be able to market material as API (active pharmaceutical ingredient), but the client was only currently meeting ISO standards.  They needed site-wide knowledge to close the gap between their current ISO system and the requirements of the internationally-accepted International Conference on Harmonization Q7A Guideline.

We put together a one-day training session covering the Q7A Guidelines that we could repeat on-site for this client.  The goal was for all of their employees to be knowledgeable in Q7A within a short period of time.  The training consisted of discussion of how Q7A applied to this facility as well as what they had in place and how they could fill the gaps that existed with the small amount of resources that had been allocated for the project.  We broke the Q7A guideline up into five units and incorporated hands-on exercises into most of the modules for greater understanding of the material.

The client continues to close their gaps through internal training and auditing programs and is making progress toward completing their Q7A implementation plan.

Call us  at 513-860-3512 or email us at info@compliance-insight.com to discuss how we can help you be successful.