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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 recent shift in the UK's regulatory landscape, marked by the adoption of the International Recognition Procedure (IRP) by the Medicines and Healthcare products Regulatory Agency (MHRA), is a significant milestone for the pharmaceutical industry. This new procedure, which replaced the European Commission Decision Reliance Procedure (ECDRP) as of...
At Navitas Life Sciences, we are at the forefront of providing comprehensive regulatory services that ensure compliance, accelerate time-to-market, and enhance patient outcomes. Our commitment to innovation, precision, and excellence helps us shape personalised solutions to support across the entire product lifecycle. Navitas Life Sciences understa...
How Navitas Life Sciences grew to be a Strategic Partner for Top Pharma across the World Clinical trials are the backbone of modern medical advancements, driving the development of new treatments and therapies that improve patient lives. For the past three decades, Navitas Life Sciences has been at the forefront of supporting and transforming the c...
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...
Data management services are a critical component of any clinical trial's success. For clinical research organizations, the integration of advanced clinical data management services can make or break the efficiency and reliability of their studies. Understanding the meaning of clinical data management is essential, as it encompasses the collection,...