www.axon-cro.com

Regulatory support is crucial to all phases of the drug development process. Axon CRO is dedicated to providing you with strategies for success of your development program. Our focus is to expedite the regulatory review process and shorten drug development timelines.

Axon CRO can assist you with regulatory and ethics committees (multicentre and local) submissions. We have broad range and depth of experience in coordinating, managing, and filing complete and partial regulatory submissions in the Central, and Eastern Europe.

We can negotiate Regulatory Authority consultation as well. Our services are tailored to each project.

Regulatory Consulting Services

• Expert advice and guidance on all regulatory issues
• Proactive liaison and interface with regulatory authority and ethics committees review
• Planning strategies and approaches for most effective and timely review /approval of regulatory submissions
• Pre-submission meetings with Axon CRO and regulatory authority
• Comprehensive clinical trial document preparation/review
• Ensuring site compliance with ICH GCP and other guidelines