Rakesh Sutariya is the visionary Managing Director and CEO of Zenovel, bringing over 17 years of expertise in strategic marketing, operation management, business development, bio-analytical, clinical, and IT fields. He has successfully monitored, audited, and conducted over 1,000 clinical trials, while
helping design and execute complex studies for regulatory submissions. Under his leadership, Zenovel
has served over 150 global clients across 45 countries, supporting pharmaceutical development through GCP, GMP, and regulatory services. His leadership at Zenovel is marked by his hands-on approach,
overseeing team and collaborating closely with various departments to ensure the company’s growth
and success.
His approach to quality is driven by a commitment to ethical practices and maintaining the highest standards in every aspect of operations. For Mr. Rakesh, “Quality is not just about achieving results—it’s about doing so in a way that aligns with Zenovel’s core values of compassion, wisdom, and excellence”. He believes in empowering his team through continuous learning and development, ensuring they stay at the forefront of industry innovations while maintaining a keen focus on regulatory compliance
Mr. Rakesh’s client approach is proactive and collaborative. He views every client partnership as an extension of Zenovel’s mission to deliver safe, effective, and reliable pharmaceutical solutions. His philosophy centers on providing tailored, cost-effective services, and fostering open communication, ensuring that clients feel supported throughout their journey.
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
