EKG Labs

Extractables and Leachables USA Sponsors

EKG Life Science Solutions, LLC (EKG Labs) is an analytical service provider supporting the development of drug-device combination products, medical devices and pharmaceuticals.  Our services support research, development and regulatory submission activities.  We are a woman owned business and our staff has decades of experience working with medical device and pharmaceutical companies developing products.

At EKG Labs, we are building an organization which focuses on the unique needs of companies seeking to develop products with both medical device and pharmaceutical attributes.  Each drug-device combination product requires a unique development approach, and we have brought together a team of experts to help each of our clients navigate their specific analytical and regulatory hurdles.

Being an expert in drug-device combination products requires us to have a superior understanding of pharmaceutical development.  Our strong foundation in numerous analytical techniques, cGMP/GLP regulations and years of practical experience gives us the tools help you achieve our client’s development goals.

EKG Lab’s leverages its wealth of medical device and pharmaceutical knowledge to provide a variety of services including:

  • Extractables and Leachables
  • Material Compatibility Testing
  • Chemical Characterization
  • Impurity Identification
  • Method Development
  • Method Validation
  • Material Specialties
  • Deformulation
  • Failure Analysis
  • Auditing Services
  • FDA Remediation