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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...
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,...
The International Clinical Trials Day brought to the fore the significance of Clinical trials in supporting medical advancements. Clinical Trials provide the necessary data to bring new treatments to the market. Contract Research Organizations (CROs) play a pivotal role in this process, offering comprehensive support for the planning, execution, an...
“Congratulations on the PMDA approval, that is a huge accomplishment. The submission would never have been possible without your hard work and dedication. Thank you.” Senior Director, Biostatistics Programming, Global Biopharmaceutical Company talking about our Global FSP solutions. Expertise, hard work, dedication, and high quality h...
Patient-centric clinical trials, which are likely to be more efficient, productive, and engaging with patients and their needs, are at the forefront of Navitas Life Sciences' approach. The Society for Clinical Trials (SCT) 2024 theme, 'It takes a village: Patient-centered partnerships in clinical trials,' resonates deeply with us. As one of the lea...