MEET THE TEAM
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.
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
