We'll pair you with former FDA and industry professionals who have extensive knowledge of FDA's current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.
We bring direct experience in pharmaceutical, biologic, and medical device and diagnostic manufacturing to help you with GMP quality assurance.
Our team conducts study-specific GCP audits of protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports for a wide variety of clinical studies all over the world.
Our quality assurance personnel provide comprehensive auditing services for all types of laboratories.
Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations.
Our data integrity, validation, and quality experts perform comprehensive computer systems and data assessments to ensure your system requirements are fully met and adequately documented.
