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Insights from the PHUSE Chennai SDE Navitas Life Sciences was proud to be part of the highly attended PHUSE India SDE in Chennai, sharing our expertise in biostatistics, data sciences, and regulatory submissions. We were recognized as a Major Contender in the Everest Group Clinical Data Management Operations PEAK Matrix® Assessment 2025, which...
The pharmaceutical industry is at a turning point in how it manages regulatory submissions. Agencies across the world, from the U.S. Food and Drug Administration (FDA) to the European Medicines Agency (EMA), are demanding structured and timely submissions. Companies that continue relying on legacy publishing systems risk operational bottlenecks, co...
Real World Evidence Market size The healthcare and pharmaceutical landscape is changing at an unprecedented pace. Traditional randomized controlled trials (RCTs), while the gold standard, are not always enough to answer today’s complex clinical questions. This is where real world evidence (RWE), generated from real world data (RWD) such as p...
If you own an API and your next milestone depends on a clean, fast review of your Drug Master File (DMF), this one’s for you. At Navitas Life Sciences, we help sponsors move from document chaos and last-minute firefighting to a predictable, tech-enabled regulatory submission engine, purpose-built for DMFs (drug master file / master drug file...
Real World Evidence: From Data to Decisions The pharmaceutical industry is undergoing a fundamental shift. Traditional randomized controlled trials (RCTs), while critical, often leave gaps in understanding how therapies perform in diverse, real-world settings. Real world evidence (RWE), drawn from real world data (RWD) such as electronic health rec...
What began in 2012 as a conventional regulatory services engagement between Navitas Life Sciences and a Top 5 pharmaceutical company has since evolved into a resilient, forward-thinking partnership, spanning more than a decade. This transformation reflects the power of a model that delivers scalability, flexibility, and sustained excellence in regu...
Navitas has been named a ‘Major Player’ in ‘IDC Marketscape : World Wide Life Sciences R&D Pharmacovigilance Technology Solutions & Consulting Services 2025 Vendor Assessment’ In the life sciences pharmaceutical industry, patient safety is the foundation. As new therapies are developed and launched at unprecedent...
Artificial Intelligence is changing the way we think about clinical trials. It’s not a future promise anymore. It’s here, now, and it’s making trials smarter and more efficient. As a US based CRO headquartered in Maryland, we’ve seen first-hand how AI is transforming operations for biotech and pharmaceutical companies ac...
Welcome to "Ask Your Biostatistician," a new expert led series from Navitas Life Sciences. Each edition explores foundational concepts that shape clinical research success, starting with a topic that’s often underestimated but absolutely vital: sample size calculation. Getting It Right from the Start: Strategic Sample Size Selection in Clini...
Ready to Launch your next Registry? So are we! Clinical research organizations (CROs) play a vital role in advancing medical knowledge and improving patient care. With the growing prominence of patient registries in clinical research and real world evidence (RWE) generation, sponsors are recognizing the need for specialized expertise from a patient...