CMC Development
Accelerating Product Development with Integrated Expertise, Advanced Technology, and Comprehensive CMC Solutions
Accelerating Product Development with Integrated Expertise, Advanced Technology, and Comprehensive CMC Solutions
We offer comprehensive CMC development services for pharmaceutical and biotechnology industries, utilizing advanced methodologies and technologies for seamless product development, scaling-up, and launch.
Rigorous processes in CMC are essential for drug development success. From pre- formulation to commercial launch, Zenovel’s all-inclusive CMC Development Services cover every phase, assuring that your drug candidates are developed to the highest standards of effectiveness, efficiency, and compliance.
Our interdisciplinary team combines knowledge in chemistry, manufacturing, regulatory affairs, and quality control to deliver solutions.
We offer flexible, tailored, and innovation solutions to meet the specific needs of your projects.
We adhere to the highest standards of regulatory compliance.
In the pharmaceutical and biotechnology industries, obtaining regulatory approval is essential prior to introducing new drugs or biologics to the market. A pivotal aspect of this approval process is the FDA Pre-Approval Inspection (PAI), which involves a comprehensive assessment of manufacturing facilities, processes, and data integrity to ensure adherence to
Risk-Based Monitoring (RBM) is a more efficient alternative to traditional clinical trials, focusing on high-risk areas through data-driven insights. It ensures patient safety, data integrity, and regulatory compliance while reducing costs and timelines. However, the success of RBM depends on the competency of monitors, who identify risks, analyze data, and
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
