
How cGMP Consulting Can Accelerate Drug Development & Approval
The pharmaceutical industry is growing and changing rapidly. As a result of this emergence, getting a new drug to the
We Embody a Legacy of Incredible Discoveries, Exploring the Boundaries of Innovation and Science

At Zenovel, we integrate our extensive expertise across a wide range of domains, from Good Clinical Practice to Regulatory Affairs, to present valuable insights and thought leadership. Each blog reflects our intense dedication to innovation, offering a forum to share our perspectives, groundbreaking ideas, and industry expertise. Through our blogs, we hope to uplift, inform, and support scientific, medical, and pharmaceutical innovation.

The pharmaceutical industry is growing and changing rapidly. As a result of this emergence, getting a new drug to the

In the ever-changing and competitive pharmaceutical and biotechnology industry, long-lasting success requires strategic foresight, flexibility, and a firm grasp of

Clinical trials are the backbone of pharmaceutical innovation; ensuring new treatments are safe and effective. However, managing these trials is

Moving forward into 2026, the pharmaceutical and healthcare industries are embarking on a transformation with artificial intelligence (AI) as a

In today’s era, Zenovel is enhancing Pharmacovigilance, the monitoring and evaluation of pharmaceutical products, by promoting international collaboration, utilizing advanced

Pharmacovigilance is crucial for public health, ensuring the safety and effectiveness of medicinal products throughout their lifecycle. It involves periodic

Clinical trials play a vital role in the development of new medications, ensuring they are safe and effective before reaching the market. Throughout the drug development process, treatments progress through various trial phases, each providing deeper insights into their potential benefits for patients. Effective clinical trial management (CTM) is critical

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