4 services found
AGC Biologics Services
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Quality Assurance and Regulatory
AGC Biologics’ quality organization provides a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services. At each of our manufacturing facilities, highly trained Quality Units maintain strict quality systems to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.
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Regulatory Track Record Services
AGC Biologics has a strong regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Danish Medicines Agency (DMA), the Paul Ehrlich Institute (PEI), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA). The many audits and inspections conducted at AGC Biologics have helped us continuously hone our quality culture and systems and further ensure ...
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Quality Assurance Services
At AGC Biologics, the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our intent focus of our customers’ compliance needs, we track new regulations and monitor and implement new regulatory trends. Our Quality Assurance teams are dedicated to ensuring compliance with all necessary regulations and ...
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Process Validation Services
For customers preparing for commercial approval and post commercial approval, Process Validation is a critical and significant set of activities. AGC Biologics has a well-defined approach with supporting Quality Systems to provide you with a targeted path through late-phase Process Validation. Our systems are based on the FDA’s 2011 Approved Guidance for Industry and ICH guidelines, using a risk-based lifecycle approach and consists of three ...
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Analytical Development Services
AGC Biologics develops analytical methods for product release, product characterization and process development support.
Robust and validated release methods, including bioassays, are developed to ensure the identity, safety, purity and potency of your product. Our in-house bioassay group specializes in analytical development and validation of cell-based assays. This speeds results and eliminates the need for third party ...