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.
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
Over the past few decades, clinical trial monitoring has significantly changed from conventional on-site visits to remote and risk-based monitoring with technology. These developments revolutionized clinical trial conduct, with enhanced efficiency, cost reduction, and increased data quality. At Zenovel, we are leading the charge in excessing these innovations to optimize
The pharmaceutical industry is heavily regulated, and compliance with strict standards is crucial for operational excellence and avoiding penalties. To achieve regulatory readiness, pharmaceutical quality leaders use proactive preparation methods like mock inspections and compliance gap analysis. Zenovel guides companies through these processes to strengthen quality systems, enhance staff readiness,
Quality and compliance are paramount in the life sciences and pharmaceutical industry. Regulatory agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) have established rigorous requirements that rely on a holistic approach to quality assurance (QA) and validation. At Zenovel,
