Blogs & Articles

White Paper: The Evolving Landscape of Global Clinical Trials (2024-2029)

The global clinical trials industry is poised for significant growth in the coming five years, driven by a confluence of factors. This white paper explores the anticipated trajectory of this growth, analyzing market size, geographical distribution, key players, emerging trends, and the impact on employment. Continue reading

India's Revised Schedule M for GMP: Ensuring Quality and Aligning with Global Standards

The Indian pharmaceutical industry is a crucial player in the global healthcare landscape, supplying affordable and quality medicines to millions worldwide. To maintain this reputation and ensure the safety and efficacy of its products, the Indian Health Ministry has revised Schedule M of the Drugs and Cosmetics Rules, Continue reading

Unveiling Risks: Key Post-Marketing Safety Issues Identified by EMA Inspections in 2023

The European Medicines Agency (EMA) plays a crucial role in ensuring the safety and efficacy of medicines throughout their lifecycle. Through pharmacovigilance inspections, the agency assesses the systems pharmaceutical companies have in place to detect, assess, understand, and prevent adverse events associated with their Continue reading

Key Findings of USFDA 483s Issued to Bioequivalence Facilities in 2022 and 2023

CRQA has analysed the key findings of USFDA Form 483 observations issued to bioequivalence facilities in 2022 and 2023. This can help identify areas for improvement and ensure compliance with regulations. Summarised below is the breakdown of the key observations: Continue reading

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