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A case study in managing 40 sites, nearly 600 randomized subjects and complex clinical endpoints across multiple geographies Complex ophthalmology trials require precise site execution, strong patient engagement, robust data management, rigorous statistical analysis and continuous regulatory readiness. Navitas Life Sciences, a global CRO, conducted...
pharmaREADY 2026: Building the Future of Regulatory Operations with AI, eCTD 4.0 and Connected Technology From regulatory publishing to intelligent, connected regulatory operations, the latest pharmaREADY User Group Meeting brought together industry perspectives, technology roadmaps and practical insights on what comes next. On August 27, 2026, Nav...
FDA’s New Draft Guidance on Container Closure Systems: What Drug Developers Need to Know A risk-based approach puts packaging suitability, compatibility and performance firmly within the broader CMC strategy For nearly three decades, the FDA’s approach to container closure systems (CCSs) for human drugs and biological products has bee...
From diabetes management to obesity, cardiovascular risk and emerging metabolic indications, GLP-1 therapies are changing what sponsors expect from clinical development. The next challenge is not simply developing another GLP-1. It is designing and executing the right study, in the right patients, with the right evidence. The GLP-1 revolution has m...
What pharmaceutical companies in India need to know about Schedule M, inspection readiness and building an effective pharmacovigilance system On 3 June 2026, CDSCO issued a circular on the implementation of the Pharmacovigilance (PV) System under Schedule M of the Drugs & Cosmetics Act, 1940 and the Rules made thereunder. The circular specifica...
The U.S. biopharmaceutical industry is entering a new phase of innovation, one shaped by increasing R&D costs, impending patent expirations and the growing need to strengthen development pipelines through external innovation. As a result, cross-border licensing has become an important strategy for biopharma companies seeking to accelerate drug ...
Five Mistakes Companies Make During eCTD 4.0 Implementation And How to Avoid Them The regulatory landscape is entering one of its most significant periods of transformation since the adoption of electronic submissions. As health authorities worldwide prepare for eCTD 4.0 implementation, pharmaceutical, biotechnology and medical device companies fac...
Meet Navitas Life Sciences at Pharmacovigilance India 2026 As the pharmaceutical industry embraces artificial intelligence, real-world evidence and increasingly complex global regulations, Pharmacovigilance India 2026 promises to be one of the most influential forums for shaping the future of drug safety. Bringing together regulators, pharmaceutica...
Drug development begins with one fundamental question: How does the body handle a drug and how does the drug affect the body?The answer comes from pharmacokinetic (PK) and pharmacodynamic (PD) studies, which form the backbone of early clinical development. Whether developing a new molecular entity, a generic drug or a biosimilar, sponsors rely on p...
Boutique by Design. Outcome-focused by Model. As clinical trials become increasingly complex, sponsors need more than functional support, they need expert clinical data science expertise that transforms data into confident decisions. The clinical research industry is entering a new phase of complexity. Global clinical trials are becoming larger, mo...