Pharmaceutical

Accelerating time-to-market

We’ve worked with virtually all of the big Pharma firms on both research-based and development-based projects. Importantly, we are familiar with FDA Part 11 compliance requirements, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Processes (GMP), and other regulations that govern the FDA approval process.

For example, we worked with a major pharmaceutical company to develop an FDA-validated inventory tracking system for its drug-related products and materials. We also delivered a clinical results tracking application, with more than 15 different studies currently tracked by the system; it is in the final stages of FDA validation. By supporting FDA-regulated processes to ensure successful trials, the applications increased investment protection and efficiency in the clinical trial process, met federal requirements, and accelerated time-to-market.