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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 ...
Every year, February 11 marks the International Day of Women and Girls in Science, a day dedicated to recognizing the contributions of women in science, technology, engineering, and mathematics (STEM). The Gender Gap in Science: Challenges and Progress Despite the groundbreaking work of female scientists like Marie Curie, Rosalind Franklin, and Tu ...
At Navitas Life Sciences, we stand as a leading oncology CRO, delivering cutting edge solutions that optimize trial design, enhance patient recruitment, and accelerate regulatory approvals. With over 100 oncology clinical studies conducted, we bring deep expertise in solid and hematological tumors, including breast, lung, gastric, HCC, prostate, mu...
What is a CRO? A Contract Research Organization (CRO) is a strategic partner to pharmaceutical, biotechnology, and medical device companies, providing outsourced research activities that facilitate the efficient execution of clinical trials and regulatory processes. CROs offer expertise across clinical development, regulatory affairs, pharmacovigil...
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 (...