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.
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?