Company Profile

The staff at Global Regulatory Solutions has assisted over 150 projects for dozens of companies involving the resolution of a wide variety of regulatory concerns. We have taken this broad base of experience to refine our processes and establish a library of procedures, templates, and checklists to assist our clients. Here is a brief list of companies we have assisted:

• Gambro
• Roche
• Baxter
• Bayer
• GE Healthcare
• Siemens
• BioMérieux
• Illumina

Our staff has been involved in several FDA investigations, and can help your organization either prepare for an upcoming investigation, or assist you in resolving 483 observations. During our preparation efforts, we often take a worst case approach to the preparations so that our clients are best prepared for when the FDA arrives. Most FDA investigators are very easy to get along with, but it never hurts to be prepared for the worst. We find that taking this approach to the investigation allows our customes to best be prapared for the investigation.

Often times a 483 observation is unavoidable, and the first response to the FDA is vital. We can help you draft your response to the agency and help you to implement the changes you commit to in the response. When drafting the response letter, it is important to address all concerns listed on the 483 observation, and also specify a reasonable time for addressing these deficiencies.

We have completed a large number of medical device validations, and our proven risk based approach has never resulted in an FDA observation, and has never been rejected during a 510(k) submission. Our methods allow our customers to complete their medical device validation in a very timely, cost effective way that focuses attention on risks involved in the device. Not only to we focus on the risks associated with the device, but out test methodologies focus on the introduction of and proper handling of fault conditions. This methodology is very much in line with the FDA's guidance for infusion pumps.

A risk based approach is also an efficient method for conducting a manufacturing process validation. Each manufacturing process is very different, however the method of identifying risks that can be introduced in the manufacturing process, then subsequently identifying the critical control points allows the manufacturer to focus the validation efforts on these CCP's, reducing the documentation burden, and resulting in a validation that is more likely to result in a robust manufacturing process.

There are many tools employed at companies, some are purely software systems such as a document management system, while other involve hardware. Some of these tools are used as a key element of your quality system, and others are used to determine the quality or acceptability of your product. Which of these tools require validation, and how best to accomplish these validation? We can help you identify which tools require validation and identify methods for conducting the validation.