Empower Informed Decisions in Clinical Trials with Our Expert PK Stat Analysis
Zenovel offers complete support in pharmacokinetic (PK) stat which starts from Study Design finalisation to final review of PK stat report/SAS Output. With experience of our expert we offer for-cause investigation considering the results of the study and correlating them with any possible event during the conduct of the trial.
With for-cause investigation we can come to know the possible reason for unfavourable results and the best possible way forward for future study.
Non compartmental analysis (NCA) is the primary focus areas at Zenovel. We deliver all the necessary analysis finding for regulatory filing process
We leverage industry leading expert to analyse pharmacokinetic data using niche statistical methods, and also offer for-cause investigation considering the results of the study and correlating them with any possible event during the conduct of the trial. This helps identify reasons for unfavourable results and suggests the best course of action for future studies. Our commitment to timely completion of complex tasks ensures efficient support for studies and license applications, providing comprehensive assistance throughout the regulatory clearance process.
Welcome to the Zenovel Blog! We are a leading provider of drug regulatory consulting and education, focusing on advancing pharmaceutical innovation while ensuring safety and compliance. This blog delves into the essentials of Drug Regulatory Affairs (DRA), covering its scope, career opportunities, and intricate processes involved in bringing new drugs
The international pharmaceutical landscape is inherently connected to the global economy and global trade, which is consisted with the quality and safety assurance , well-controlled quality and safety. Compliance with international pharmaceutical standards has changed from an optional step to a requirement. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the
Lipinski’s Rule of 5 (Ro5) is a crucial guideline in pharmaceutical development, helping researchers evaluate a compound’s likelihood of becoming an effective oral drug. However, with the rapid evolution of therapeutic strategies, it’s worth considering the relevance of Ro5 in the current drug design landscape. Understanding Lipinski’s Rule of 5
Regulatory affairs (RA) play a crucial role in the pharmaceutical industry; ensuring products meet quality, safety, and efficacy. As the industry grow further the need for qualified professionals to bridge gaps between companies and regulators increases. This blog explores Zenovel regulatory affairs expertise, our various facets, and valuable contribution to
Navigating the world of pharmaceuticals, medical devices, and biotechnology is never straightforward. With the diversity of regulatory compliance governs the Code of Federal Regulations (CFR) – a regulatory path that shapes companies’ efforts and implements how companies long for their products to be developed, manufactured, and marketed. For companies trying
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: