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Audits at Syner-G BioPharma Group

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In the complex and highly regulated pharmaceutical industry, rigorous and comprehensive audits are essential for ensuring compliance, enhancing quality, and maintaining public trust. Our audit services are meticulously designed to address all regulatory and quality aspects of pharmaceutical operations, from Good Laboratory Practices (GLP) to Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and non-clinical studies.

GMP Audits

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.

GLP Audits

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.

GCP Audits

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.

GDP Audits

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 Audits

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.

Overcoming Challenges

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.

Our Audit Approach

At Syner-G, our audits are characterized by their thoroughness and attention to detail. Our experienced auditors employ a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control, and governance processes. Here are some key features of our audit methodology:

Risk-Based Auditing

We use a risk-based approach to focus our audit efforts on the areas that are most critical to your operations and regulatory obligations. This method helps to optimize resources and ensure the most impactful compliance interventions.

Regular and Ad-Hoc Audits

Syner-G offers both regularly scheduled audits and ad-hoc audits that can be conducted in response to specific issues or as part of a regulatory compliance check. This flexibility helps our clients maintain continuous compliance and address any potential issues proactively.

Follow-Up and Continuous Improvement

Following each audit, we provide detailed reports that outline any discrepancies and recommend corrective actions. Our team remains engaged to help implement these improvements and to conduct follow-up audits to ensure continuous compliance and quality enhancement.

Benefits of Choosing Syner-G for Your Audits

Enhanced Compliance

Our audits help ensure that all aspects of your pharmaceutical operations comply with international regulatory standards, helping to avoid fines and other penalties.

Compliance Assurance

Improved Product Quality by identifying and correcting potential issues before they can affect product quality, our audits help maintain high standards and consumer confidence.

Reduced Risk

Proactive identification and management of potential risks help to mitigate them before they can become serious problems, protecting your products and your brand.

Increased Operational Efficiency

Our detailed audit reports provide insights that can be used to streamline operations and improve efficiency across all phases of production and distribution.

Uphold The Highest Standards of Pharmaceutical Excellence

Learn more about how Syner-G’s Audit services can enhance the quality and compliance of your pharmaceutical operations.