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First-in-human (FIH) clinical trials mark a significant turning point in drug development, where a new therapy moves from the lab to being tested in humans for the very first time. An FIH study is not just a milestone in scientific discovery; it represents an intricate balance between innovation and patient safety. At Navitas Life Sciences, we are ...
At Navitas Life Sciences, we understand the immense impact cardiovascular diseases have on global health, making advancements in treatment essential. Cardiovascular clinical trials, including some landmark cardiology trials, are vital for testing innovative therapies and interventions that can improve patient outcomes and save lives. These trials a...
Alzheimer’s disease stands as one of the most challenging medical puzzles of our time, affecting millions of people globally. As a progressive neurodegenerative disorder, Alzheimer's leads to a steady decline in cognitive function, ultimately depriving individuals of their memory, reasoning, and autonomy. The pathological mechanisms driving ...
Navitas Life Sciences offers comprehensive regulatory services that empower pharmaceutical, biotechnology, and medical device companies to meet stringent global standards while accelerating time-to-market. By leveraging cutting-edge technologies, such as AI in regulatory compliance and reporting, the company is transforming the way organizations ma...
At Navitas Life Sciences, we pride ourselves on being at the forefront of providing comprehensive medical and regulatory consulting services that help our clients achieve operational excellence, ensure compliance, and act as a catalyst for increased competitiveness, efficiency and speed to market. As one of the top medical and regulatory consulting...
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 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...