Regulatory Compliance

Running a clinical trial outside of your own country can be stressful, especially if the region and its legal requirements are unfamiliar to you. If done incorrectly, it can cause major delays and unwanted financial costs. 

Our clinical trial regulatory support includes:

• Ethics and regulatory applications
• Routine ethics, regulatory reporting, and amendments
• Local sponsor requirements
• Compliance
• Quality Assurance
• Importation requirements
• Quality review

We also guide you through the necessary compliance for commercial products, which includes:

• Strategic and technical advice
• Pharmaceuticals, biotech, medical device, and natural health products
• New medicines applications and product life-cycle management
• Gap analysis and consolidation of regulatory submissions
• Product and labelling review
• Licensing requirements

Clients sometime prefer to handle things themselves. However, one mistake on these critical applications can throw your entire study off track. The expertise of our team can ensure that your trial is not delayed by simple errors in ethics and regulatory applications.