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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...
How biotech companies can identify the right CRO partner to accelerate patient recruitment, improve trial quality, reduce operational burden and deliver regulatory-ready data. The way clinical trials are conducted has changed dramatically over the last five years. What began as a necessity during the COVID-19 pandemic has evolved into a strategic a...
Pharmaceutical organizations are facing a new challenge that goes beyond clinical development, pharmacovigilance and regulatory submissions: controlling who can access sensitive data, where they can access it from and how every access decision is documented. Regulatory changes, strengthened national security requirements and increasingly complex cr...
Bringing a new therapy to market is one of the most significant milestones in a pharmaceutical or biotechnology company's journey. Yet, while organizations invest substantial resources in clinical development, regulatory submissions and commercialization planning, many underestimate the complexity of building a compliant and scalable pharmacovigila...