Project Management
Drive Efficient and Successful GCP-Compliant Trials with Our Expert Project Management, from Start to Finish
Drive Efficient and Successful GCP-Compliant Trials with Our Expert Project Management, from Start to Finish
Zenovel is committed to providing pharmaceutical quality control companies unparalleled support through our broad spectrum of project management services.
Sponsor of the study is ethically responsible for the safe conduct of the trial, even though the trial or study is currently being outsourced to CRO for additional technical support. To fulfil these responsibilities, all stakeholders must remain actively engaged in constant interaction and association with CRO. Zenovel acknowledges this primary obligation from the sponsors / client and pledges that all administrative and technical activities will be conducted by the CRO in accordance with the statement of work and GCP standards from the outset.
Zenovel’s project management services cover every aspect of clinical trial management ensuring comprehensive support from start to finish which includes Site Identification, Feasibility, Audit and Selection through budget finalisation, Protocol Review, Complete coordination and Monitoring of Study and for Report submission.
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
