We are all seasoned professionals who have expertise in regulatory, drug substance manufacturing, drug product manufacturing, product development, clinical trials, quality, validation, and analytical requirements; we specialize in liquid, powder and lyophilized parenterals, solid dosage forms, suspensions, and topical products in pharmaceuticals and medical devices.

Audrey Schupp
Audrey SchuppCEO
Specializing in GMP manufacturing and vendor management.


Our focus is in agency compliance in the US and around the world

We believe every product should be handled with our complete attention, and are dedicated to assuring quality and safety in our end-to-end support of your submission.

  • Gap assessments

  • System builds and remediation

  • Compliance

  • International Regulatory Compliance

  • Strategy

Your support team is hand-selected based on the unique needs and the status of your project.

Connect with us.

Please contact us with your questions and needs. Describe your situation and let us help you stay on the path for success.

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