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What is Regulatory Support?
Regulatory support is an important factor to consider when developing a medical device or pharmaceutical product. Navigating the complex regulatory environment can be a difficult, time consuming, and confusing process. Having a partner that knows the process and can anticipate problems before they happen helps you bring your product to market faster.
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Regulatory Support Services at EKG Labs
EKG Labs provides regulatory support both as part of their in-depth development services and as an independent service offering. Over the years, our team has supported large and small medical device and pharmaceutical companies in tackling a variety of regulatory challenges. We have helped our clients answer questions like:
- What testing and data do I need to support my regulatory filing?
- How do I respond to comments from the FDA?
- What do I do with a 483 or warning letter?
- How do I go about auditing a third party laboratory?
