Audits at Syner-G BioPharma Group

Our GMP audits focus on manufacturing processes, ensuring that all aspects of production adhere to quality standards that guarantee product safety and efficacy. We evaluate everything from raw material handling to final product release, ensuring compliance with all regulatory requirements for manufacturing pharmaceuticals and biologics.

Syner-G conducts GLP audits to verify that laboratory procedures and practices meet the necessary standards for conducting non-clinical laboratory studies. These audits are crucial for ensuring the quality and integrity of data that support regulatory submissions and product approvals.

Our GCP audit services ensure that clinical trials are conducted in accordance with international standards, protecting the rights, safety, and well-being of trial participants. These audits assess compliance with all aspects of clinical trial management, including trial design, conduct, performance, monitoring, and reporting.

Good Distribution Practices (GDP) are critical for maintaining the quality and integrity of pharmaceutical products during storage and distribution. Syner-G’s GDP audits examine the logistics and supply chain processes to ensure that products are stored, handled, and transported in a manner that maintains their quality throughout the distribution network.

Non-clinical studies are pivotal in determining the safety profile of a pharmaceutical product before it ever reaches human testing. Our non-clinical audits scrutinize the study conduct and data collection practices to ensure compliance with regulatory standards and scientific rigor.

From adopting new drug development paradigms to managing the demands of globalized supply chains, the challenges in CMC are manifold. Syner-G’s team of experts is skilled in turning these challenges into opportunities for faster pathway to market and streamlined R&D processes. We ensure that your development journey is marked by strategic milestones and successful outcomes.