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.
The European Union’s Good Manufacturing Practice (GMP) standards, as outlined in the Annex to the Guide to Good Manufacturing Practice for Medicinal Products, ensure the quality and safety of medicinal products, including those used in clinical trials. The Qualified Person (QP) plays a crucial role in batch certification, particularly for
In the intricate process of developing new pharmaceuticals, guaranteeing product safety, effectiveness, and adherence to global regulations is essential. Batch release testing acts as a pivotal quality assurance measure, confirming that medications comply with rigorous criteria before distribution. When combined with International Council for Harmonisation (ICH) standards, this testing framework
In the world of life sciences, quality isn’t just a benchmark—it’s the backbone of success. Three key pillars—Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)—form the core framework that supports everything from product development to regulatory approval. These standards aren’t just industry buzzwords; they’re the
In the pharmaceutical industry, quality is paramount—and at Zenovel, we are deeply committed to delivering excellence in Quality Assurance (QA). Our focus is on ensuring that every medicine is developed, manufactured, and delivered with safety and reliability as top priorities. QA is embedded in every stage of the pharmaceutical lifecycle—from
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be based on validation, a methodical procedure to verify that manufacturing procedures and equipment consistently deliver high-quality outcomes. A strong strategy to validation is required in 2025 due to the complexity
