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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...
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...
Biotech and pharma companies face increasing pressure to accelerate timelines, manage costs, cater to regulatory changes and maintain quality across global programs. As clinical trials become more complex, selecting the right outsourcing model has become a strategic decision rather than simply an operational one. Among the most widely adopted appro...
Scientific breakthroughs in oncology, rare diseases, cell and gene therapies, immunology and precision medicine are increasingly being driven by agile and innovative biotech companies rather than pharmaceutical giants alone. Yet many emerging organizations face a familiar challenge: how can they achieve the operational sophistication of large pharm...
25 Years in 25 Voices of Peer Leadership For 25 years, the forums and peer networks powered by Navitas Life Sciences have brought together pharmaceutical, biotech, pharmacovigilance and regulatory leaders to exchange ideas, solve complex challenges and support the growth of the life sciences industry. In an industry defined by rapid transformation,...
How Foundations, Biotech and Pharma Organizations Can Accelerate Parkinson’s Studies with the Right Clinical Research Partner Parkinson’s disease research is entering a pivotal era. As scientific understanding of neurodegenerative disorders expands, organizations are moving beyond symptom management toward disease modification, precis...