We Embody a Legacy of Incredible Discoveries, Exploring the Boundaries of Innovation and Science
At Zenovel, we integrate our extensive expertise across a wide range of domains, from Good Clinical Practice to Regulatory Affairs, to present valuable insights and thought leadership. Each blog reflects our intense dedication to innovation, offering a forum to share our perspectives, groundbreaking ideas, and industry expertise. Through our blogs, we hope to uplift, inform, and support scientific, medical, and pharmaceutical innovation.
The international pharmaceutical landscape is inherently connected to the global economy and global trade, which is consisted with the quality
Lipinski’s Rule of 5 (Ro5) is a crucial guideline in pharmaceutical development, helping researchers evaluate a compound’s likelihood of becoming
Regulatory affairs (RA) play a crucial role in the pharmaceutical industry; ensuring products meet quality, safety, and efficacy. As the
Navigating the world of pharmaceuticals, medical devices, and biotechnology is never straightforward. With the diversity of regulatory compliance governs the
The race to deliver life-saving therapies to patients is increasingly faster and more complex. Pharmaceutical and biotech companies are faced
In India, sponsors of clinical trials have vital responsibilities for the ethical, regulatory, and operational success of sponsored clinical trials.
The race to deliver life-saving therapies to patients is increasingly faster and more complex. Pharmaceutical and biotech companies are faced with a dizzying list of challenges — global clinical trials, continuously changing regulations, multiple complicated therapeutic areas, and pressure to innovate. This is where Contract Research Organizations (CRO) come in:
In India, sponsors of clinical trials have vital responsibilities for the ethical, regulatory, and operational success of sponsored clinical trials. As stated in the New Drugs and Clinical Trial Rules, 2019 – and the Good Clinical Practice (GCP) guidelines issued by the Central Drugs Standard Control Organization (CDSCO), sponsors have
In our fast-paced pharmaceutical industry, organizations can no longer operate their business by not only obtaining operational excellence, but also meeting stringent regulatory compliance. A strong Quality Management System (QMS) is critical to pharmaceutical operations and product lifecycle management to maintain product safety and efficacy, and regulatory compliance. At Zenovel,
Clinical trials are crucial for drug development, but managing them is complex due to the vast amount of data and patient safety concerns. Zenovel uses innovative approaches like Risk-Based Monitoring (RBM) to streamline processes, prioritize quality, and enhance trial efficiency. This blog explores RBM’s significance in clinical trials and how
In the dynamic, rapidly changing environment of the pharmaceutical industry, product quality and regulatory compliance is mandated. Computer System Validation (CSV) is essential to that goal, since it demonstrates that computerized systems used in manufacturing, testing or managing data are reliable and compliant. This Zenovel guide gives an overview of
Pharmacokinetics (PK) is a key element of drug development, and describes how a drug interacts with the body by defining its absorption, distribution, metabolism and excretion (ADME). Knowing about PK is essential in drug development to establish the safety and efficacy of drugs (both new and generic). It is Zenovel’s
