We give comprehensive, risk-based audits that uncover compliance gaps, reduce regulatory exposure, and drive continuous improvement.
Gap Assessments
Gap assessments identify weaknesses in your current processes by comparing them against regulatory requirements like FDA or ISO standards. They provide a clear roadmap for improvements, helping you achieve compliance while optimizing operational efficiency.
Good Manufacturing Practice (GMP)
Our auditors assess your facilities, systems, and procedures to verify compliance with GMP guidelines. We identify any areas of risk and recommend improvements. This service not only helps maintain regulatory compliance but also enhances product safety and quality. This minimizes the risk of non-compliance issues and supports continuous improvement in your manufacturing operations.
Good Laboratory Practice (GLP)
Our GLP auditing service evaluates your laboratory operations to verify adherence to GLP standards. This is critical for the reliability and integrity of your scientific data. Our auditors assess all aspects of your lab processes, everything from equipment calibration to data integrity, offering actionable recommendations to enhance compliance and scientific validity. This service helps maintain the credibility of your research outcomes and supports regulatory submissions.
Good Clinical Practice (GCP)
Our GCP audits review protocols, consent forms, data management, and submissions, identifying improvements and regulatory adherence. This service builds trust with participants, regulators, and stakeholders, supporting successful product approval and market launch.
Vendor/Supplier
We examine operational procedures, quality control systems, and compliance with global regulatory requirements. This helps safeguard the integrity of your supply chain. This critical service is designed to minimize risk, enhance product safety, and assures continuity and reliability in your production processes. It plays a crucial role in helping you maintain the highest standards necessary for patient safety and regulatory approval
Quality System
We evaluate compliance with ISO 13485, FDA QSR, and EMA regulations, identifying areas for improvement and enhancing operational efficiency. This guarantees your quality systems are robust, maintaining high product quality and safety for patient care and regulatory compliance.
Process
Our process audits evaluate your manufacturing and operational procedures to verify compliance with regulatory standards and best practices. We assess every step of your production processes, from initial raw material handling to the final product release, to identify inefficiencies, prevent non-compliance, and safeguard product quality.
Document
Our document audits involve a thorough examination of all documentation related to quality management systems, regulatory compliance, and operational procedures. Its purpose is to verify accuracy, completeness, and adherence to industry standards, ensuring robust documentation practices that support product safety and regulatory requirements.
Data Integrity
Our data integrity auditing verifies your data management practices strictly adhere to regulatory standards for accuracy, completeness, and reliability. We rigorously evaluate your data lifecycle processes—from data creation and maintenance to its transfer and archiving—to identify and mitigate risks of data breaches or non-compliance. This critical service helps protect the integrity of your clinical and laboratory data.
Risk-Based
Our risk-based audits prioritize high-risk areas for compliance and product quality. This strategic approach optimizes resource allocation, enhancing audit effectiveness. We identify and mitigate operational vulnerabilities to adhere to regulatory compliance and uphold safety and efficacy standards in your products. This method streamlines compliance and supports continuous improvement in your quality management systems.
Mock Inspections
Our mock inspections prepare your organization for real regulatory inspections by simulating an audit scenario conducted by regulatory bodies such as the FDA or EMA. This service identifies vulnerabilities in your processes and systems, providing a safe environment to test your readiness and train your staff. By undergoing our thorough mock inspections, you can enhance your compliance strategies, improve procedural responses, and ensure your team is well-prepared to handle actual regulatory evaluations with confidence. This proactive approach significantly reduces the risk of non-compliance and helps maintain continuous quality assurance in your operations.
Quality Agreement
Our quality agreement audits see that all contracts and agreements with suppliers, partners, and contractors meet quality standards and regulatory requirements. We examine the terms and responsibilities outlined in your quality agreements to verify that they are comprehensive and enforceable, align with industry best practices, and support compliance with applicable global regulations.
Compliance
We evaluate your operational, clinical, and manufacturing processes to identify compliance risks and areas for improvement. This helps safeguard against regulatory penalties and enhances product reliability by ensuring your practices meet the strict requirements set by authorities like the FDA and EMA. Through these audits, we help you maintain the highest standards of compliance, supporting your commitment to patient safety and product quality.
Adverse Event Reporting
Our adverse event reporting audits critically assess your systems and processes for monitoring, documenting, and reporting adverse events. This ensures your practices comply with regulatory requirements for pharmacovigilance and are capable of promptly and accurately reporting safety issues to relevant authorities. By enhancing your adverse event reporting procedures, we help you maintain patient safety, meet regulatory obligations, and uphold public trust in your products.
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