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Accelerating First-to-Market Success in Generics Bioavailability and Bioequivalence (BABE) studies are critical gateways to bringing safe, effective, and affordable generic medicines to market. With over 90% of US prescriptions filled by generics, ensuring robust clinical execution and data integrity has never been more important. Digital Precision...
The complexities and challenges of data is increasing at an unprecedented rate and excellence in Clinical Data Management (CDM) has become a defining factor of success. Pharmaceutical and biotech companies are looking for partners who not only manage data but transform it into meaningful insights that drive smarter and more compliant decisions. In ...
The second Navitas Life Sciences Ad Promo Roundtable, held on September 25, 2025, convened more than forty experts from across global pharma to examine recent U.S. FDA actions on Direct-to-Consumer (DTC) advertising. Highlights from the Second Ad Promo Roundtable The session was Co-Hosted by Bob Dean, Head of Global Labeling Strategy and Ad/Promo, ...
Be First-to-Market with Our Bioavailability & Bioequivalence (BABE) CRO Services Bioavailability (BA) and Bioequivalence (BE) studies are critical components in developing or marketing a generic drug. To secure approval from global health authorities such as the US FDA, pharmaceutical companies must conduct a bioequivalence study comparing thei...
Navitas Life Sciences’ medical information contact center (MICC) services help global clients achieve operational excellence, ensure compliance and enhance customer satisfaction while significantly reducing costs. Our proven approach recently enabled a leading global pharmaceutical company to achieve a 30% cost reduction through an integrate...
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...