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From consulting on clinical trials or new product submissions to training and audits, we offer a wide variety of services–all performed with equal expertise and efficiency.
- How to Compare Regulatory Consultants April 30, 2021 - When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultants are an excellent option. Choosing the right consultant can help your organization avoid compliance problems and improve the time-to-market for your product. Read More
- Management’s Role in Developing a cGMP-compliant QS April 22, 2021 - Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key to setting up and maintaining a robust QS. Read More
- 5 Labeling Changes that Require a New 510(k) April 20, 2021 - Medical device labeling changes are made for a wide array of reasons. When a manufacturer makes changes to the labeling for a medical device, they must assess the impact of the change against their 510(k) clearance. Some changes may require a new 510(k) submission. Others don't… Read More