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In the intricate world of pharmaceutical development, where the stakes are high, deadlines are tight, and precision is non-negotiable, the role of medical writing has never been more crucial. Against this backdrop, our recent Medical Writing Roundtable, co-led by Novo-Nordisk, brought together industry leaders from nine global companies, from EU, U...
Designing complex innovative protocols for Oncology clinical trials is a complex process that must balance scientific rigor, regulatory requirements, and patient-centric care. This process has become increasingly critical as advancements in genomics, immunotherapy, and other novel therapeutic strategies are reshaping cancer treatments. By integrati...
Driving transformation in the drug development landscape requires more than just adapting to changes; it demands leading them. At Navitas Life Sciences, we don't just overcome complexities of clinical trials—we shape them, setting new standards for efficiency, precision, and compliance. By integrating cutting-edge technology and a deep under...
As we mark Immunization Awareness Month 2024, it's imperative to spotlight the critical role of vaccines in public health and the intricate processes behind their development. At Navitas Life Sciences, our commitment to combating infectious diseases through rigorous clinical trials underscores our dedication to advancing global health. With over 30...
The recent announcement by the US Food and Drug Administration (FDA) regarding laboratory-developed tests (LDTs) indicates that increased enforcement of established medical device regulations will now apply to all in vitro diagnostic (IVD) products, including LDTs. The FDA LDT announcement, referring to the previous FDA LDT ruling, marks the end of...
The global clinical trials market, valued at USD 80.7 billion in 2023, is projected to grow at a compound annual growth rate (CAGR) of 6.49% from 2024 to 2030. This expansion highlights the critical importance of selecting the right Contract Research Organization (CRO) to manage efficient and compliant clinical trials. In our latest blog, we discus...
By reimagining regulatory submission strategies with artificial intelligence in regulatory affairs, pharmaceutical companies can expedite timelines and boost their chances of successful product approvals. To accelerate the market entry of new products, there is a need to increasingly focus on regulatory submissions as a critical area for developing...
At Navitas Life Sciences, we believe in not just advancing the frontiers of pharmaceutical sciences but also in giving back to society and academia. Dr Latika Sharma, MBBS., MD, our PV Networks Lead, led an insightful seminar as a part of clinical research & pharmacovigilance training on “Pharmacovigilance: Trends, Opportunities & Ch...
In the fight against counterfeit medicines, the stakes are incredibly high. Counterfeit drugs pose significant threats to public health worldwide, with far-reaching consequences, especially in regions with limited regulatory oversight. At Navitas Life Sciences, we are dedicated to addressing these challenges head-on. Recently, Dr. Philipp Hofmann, ...
There is an increasing focus on diversity in clinical trials, which is crucial for providing essential data on the safety and efficacy of new treatments before they are approved for widespread use. However, a significant issue plaguing the clinical trial process is the underrepresentation of older adults. This lack of age diversity in clinical tria...