Ensure pharmaceutical excellence by one batch at a time
We extend batch release and testing site support services to ensure your products meet high quality and compliance standards. We understand the importance of precise and timely batch release and testing, and are dedicated to supporting your success.
We provide GMP-certified importation, batch testing, and batch release services for human, veterinary, and investigational medicinal products. With multiple QPs and MIA holders, we can perform GMP batch testing and release for sterile, non-sterile, and biological medicinal products. Most of our clients are global manufacturers without mutual recognition agreements (MRA) importing their products within the developed countries. Batch testing is mandatory before batch release, and Zenovel’s integrated solution includes batch release for these manufacturers, allowing them to entrust their products until market release.
Our team of professionals brings extensive experience in pharmaceutical quality control and regulatory affairs.
We advanced testing and release services are powered by state-of-the-art laboratories and advanced technologies.
We work thoroughly with our clients to fully grasp their individual demands and then customise our offerings to fulfil those needs.
Our commitment to strict regulatory standards and integrity ensures the safety and effectiveness of our products in all our operations.
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: