GMP Services
Elevating Quality Standards and Building Trust through Compliance with Comprehensive GMP Excellence Services.
Elevating Quality Standards and Building Trust through Compliance with Comprehensive GMP Excellence Services.
Zenovel is distinguished for its expertise in Good Manufacturing Practice (GMP) services, especially within the life sciences and pharmaceutical sectors. With over 17 years of experience, we excel in supply chain management and supplier qualification. Our comprehensive GMP services benefit companies globally, including pharmaceutical enterprises, by ensuring unparalleled quality and compliance across all manufacturing operations. These GMP services are aligned with global regulatory expectations outlined by the World Health Organization (WHO) and international GMP guidelines to ensure consistent quality, safety, and compliance.
A team of skilled, experienced, and qualified professionals with more than 17 years of field experience.
Offers services through efficient project management, effective streamlined process, and advanced tracking systems, backed by a dedicated and experienced team.
Implementing strict data security protocols, secure communication channels, strict adherence to confidentiality agreements and regulatory requirements.
Offers a comprehensive GMP services consisting of supply chain management, supplier qualification, and stringent quality control and regulatory compliance.
Ensures by high rigorous auditing, adherence to high standards regulatory compliance, and proactive risk management strategies.
In the pharmaceutical and biotechnology industries, obtaining regulatory approval is essential prior to introducing new drugs or biologics to the market. A pivotal aspect of this approval process is the FDA Pre-Approval Inspection (PAI), which involves a comprehensive assessment of manufacturing facilities, processes, and data integrity to ensure adherence to
Risk Based Monitoring (RBM) is a more efficient alternative to traditional clinical trials, focusing on high-risk areas through data-driven insights. It ensures patient safety, data integrity, and regulatory compliance while reducing costs and timelines. However, the success of RBM depends on the competency of monitors, who identify risks, analyze data,
Welcome to the Zenovel Blog! We are a leading provider of drug regulatory consulting and education, focusing on advancing pharmaceutical innovation while ensuring safety and compliance. This blog delves into the essentials of Drug Regulatory Affairs (DRA), covering its scope, career opportunities, and intricate processes involved in bringing new drugs
The international pharmaceutical landscape is inherently connected to the global economy and global trade, which is consisted with the quality and safety assurance , well-controlled quality and safety. Compliance with international pharmaceutical standards has changed from an optional step to a requirement. The Pharmaceutical Inspection Co-operation Scheme (PIC/S Certification) is
Lipinski’s Rule of 5 (Ro5) is a crucial guideline in pharmaceutical development, helping researchers evaluate a compound’s likelihood of becoming an effective oral drug. However, with the rapid evolution of therapeutic strategies, it’s worth considering the relevance of Ro5 in the current drug design landscape. Understanding Lipinski’s Rule of 5
Regulatory affairs (RA) play a crucial role in the pharmaceutical industry; ensuring products meet quality, safety, and efficacy. As the industry grow further the need for qualified professionals to bridge gaps between companies and regulators increases. This blog explores Zenovel regulatory affairs expertise, our various facets, and valuable contribution to
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