Clinical Trials Regulatory Affairs and QA

Taking a drug to market is a highly-regulated process. Medelis provides clients with the regulatory, clinical and quality assurance guidance to ensure that clients meet all the necessary governmental requirements throughout the process.

Medelis maintains its own corporate Standard Operating Procedures (SOPs) which govern critical trial operations. Our SOPs were designed by and are monitored and updated by team members with deep regulatory expertise. We update our SOPs annually, and also create study-specific SOPs as required.

Medelis also offers regulatory support for both sponsors and investigators to ensure compliance with applicable regulations. We handle all necessary audits, training and submissions to ensure compliance runs smoothly throughout the trial.