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The pharmaceutical industry is undergoing a significant transformation driven by digital innovation and artificial intelligence (AI). It has become increasingly beneficial to leverage AI powered tools and cloud based regulatory solutions to streamline regulatory submissions. These advancements enhance efficiency, improve data exchange, and ensure c...
The global generics market is on an accelerated growth path, with the U.S. leading the way, projected to surpass USD 508.37 billion by 2034 at a CAGR of 12.00%. This momentum is driven by rising healthcare costs, expiring patents, and increasing regulatory support for generic drug approvals. However, growth brings complexity. Regulatory scrutiny is...
Ensuring Compliance with the Windsor Framework The Windsor Framework is now implemented, transforming the regulatory landscape for pharmaceutical companies operating in the UK. While the framework simplifies processes by enabling a UK-wide licensing system under the Medicines and Healthcare products Regulatory Agency (MHRA), companies that have not...
Phase 1 clinical trials are the foundation of clinical drug development, marking the transition from laboratory research to human testing. These first-in-human trials are designed to evaluate the safety, dosage, and pharmacokinetics of investigational drugs in a small group of healthy volunteers or patients. The insights gained at this stage are cr...
In January 2025, we were honoured with the EcoVadis Bronze Medal for our sustainability initiatives. This recognition affirms our dedication to sustainability and strengthens our position as a leading CRO that integrates responsible business practices into every aspect of clinical trials. "We take great pride in integrating ESG principles into our ...
Glaucoma remains a leading cause of irreversible blindness worldwide, affecting millions of people and posing significant challenges for healthcare systems. Despite advancements in diagnostics and treatment, the complexity of the disease—characterized by its silent progression and multifactorial nature—demands a continuous evolution i...
The US Food and Drug Administration (FDA) recently provided a draft guidance on the application of artificial intelligence (AI) in regulatory decision making. By championing a balance between innovation and safety, this initiative highlights the significance of AI while upholding its rigorous scientific and regulatory standards. Entitled ‘Co...
The clinical trials landscape in 2025 is shaped by technological advancements, regulatory shifts, and a growing demand for innovative therapies. In our latest blog we explore key developments that are poised to leave a lasting impact on clinical trials. 1. AI and Machine Learning: Moving from Hype to Practical Applications Artificial Intelligence (...
Navitas Life Sciences has been at the forefront, sharing knowledge and driving impactful discussions. Here’s a roundup of our top 10 blogs for 2024 that captivated readers and enriched the life sciences community. 1. The Impact of Generative AI in Clinical Trials Generative AI, a specialized branch of Artificial Intelligence (AI), offers tra...
In a recent episode of The Gens & Associates Podcast, host Steve Gens engaged in a compelling discussion with Navitas Life Sciences' leaders: Marty Boom, Global Head of Regulatory & Safety, and Tris Nockles, Labeling Networks Lead. The conversation explored Navitas' innovative "nets" framework, the integration of AI and automation in regula...