GMP Consulting Services
Guiding You Through Every Step of the Manufacturing Cycle by Expert Consulting Solutions
Guiding You Through Every Step of the Manufacturing Cycle by Expert Consulting Solutions
We offer a complete GMP consulting services designed to help your organization to achieve and maintain highest standards of quality compliance.
Zenovel is a reliable GMP consultant for pharmaceutical companies worldwide, offering a comprehensive range of services on a convenient platform. We provide scientific guidance and cost-effective solutions, thanks to our professionally developed SOPs, documentation, and knowledgeable staff. This ensures the most effective and efficient GMP consulting services.
We are specialists in product quality for the regulated life sciences sector, including pharmaceuticals, biotech, and medical devices. Our services cover the entire product development lifecycle, from raw materials to patient delivery. We offer consulting and advising services like quality management systems, mock inspections, equipment certification, computerized system validation, and plant engineering evaluations, tailored to each customer’s unique needs.
Our consultants, with extensive experience in Regulatory compliance consulting
and quality management, offer crucial support to ensure your organization adheres to the highest GMP standards.
We employ a tailored solution for efficient management such as mitigation approaches, risk assessment, prioritization, continuous monitoring strategies based on identified risks.
The company’s success is attributed to its extensive experience, meticulous attention to detail, and successful regulatory compliance solutions.
We ensure integrity, transparency, and commitment to ethical standards in all areas.
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
