Regulatory Support Services

  • 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
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?
Our regulatory support and quality system capabilities include:
Regulatory Support Product Experience