Expert Articles
Clinical Trials
Contract Research Organizations (CROs) provide a wide range of services that support Pharmaceutical companies throughout the Drug development lifecycle. Their expertise ranges from early-stage Drug discovery and preclinical research, Clinical Trial management, Regulatory affairs, and operational support. They help streamline development activities, enhance productivity, and accelerate the path to Regulatory approval by offering specialised scientific,
Clinical Trials
Vaccine Clinical Trials in India: Vaccine Development Regulatory Pathway
Vaccine Clinical Trials are a critical component of vaccine development, ensuring that vaccines are safe, effective, and suitable for public use before widespread deployment. India has established a robust Clinical Research ecosystem supported by strong Regulatory oversight, experienced investigators, and extensive manufacturing capabilities. The country’s success in conducting large-scale Vaccine Trials, particularly during the COVID-19
Clinical Trials
Clinical Trials For Vaccines in India: Step-by-Step Guide
Vaccine clinical trials in India follow a highly structured and regulated pathway to ensure safety and effectiveness before public use. The clinical trial for vaccines in India begins with research and preclinical studies, followed by Phase I–III human trials to evaluate safety, dosage, and immune response. After a stringent review by CDSCO in compliance with
Biologicals |
Clinical Trials
CDSCO Guidelines for Biological Clinical Trials in India (NDCT Rules 2019)
CDSCO Guidelines for Biological Clinical Trials in India (NDCT Rules 2019) define a structured regulatory pathway for evaluating biologics through phased human studies. The framework ensures safety, quality, and efficacy through strict documentation, ethical approval, GCP compliance, and scientific review. It supports safe development of vaccines, gene therapies, and other biologics before market authorization in