Precise & Efficient

Through our clinical trial regulatory support, we help you navigate through the various – and often complex – regional regulatory requirements to ensure that your trial achieves rapid regulatory approval and a successful market entry.

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

Solving Application Issues

The costly impact of doing your own ethics and regulatory applications

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.



Full Service Project Management

Outsourced Clinical Research

Regulatory Compliance

Quality Assurance

Rescue Studies

Rapid Regulatory Approvals and Successful Market Entries

Pre-study Feasibility

Call us to discuss your next study and how our regional expertise can ensure your trial is a success.

At no cost, we can prepare a draft proposal, outlining possible sites, estimated costs and do-ability in this region.