Clinical Research Solutions
FDA Publishes over 200 Complete Response Letters (CRLs)
On July 10th, 2025, the FDA announced its decision to publish over 200 Complete Response Letters (CRLs) issued between 2020 and 2024. This decision marks a seismic shift in the way our industry...
Clinical Research Solutions
Navigating the Transition from ICH E6 (R2) to (R3)
Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the...
Clinical Research Solutions
Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance
In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...
Clinical Research Solutions
GxP Readiness and Auditing: Your Quality System’s Insurance Policy for Compliance Systems
In the world of pharmaceuticals, biotech, and medical devices, maintaining compliance with Good Practices (GxP) is critical to ensuring product safety, efficacy, and quality. But how do companies...
Clinical Research Solutions
Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development
In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...
Clinical Research Solutions
Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...