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www.axon-cro.com

 

Regulatory Services

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

Our regulatory support covers clinical trial process during its all stages (from submission to final report) according to ICH GCP, regulatory needs and local law.

 

Axon CRO, s.r.o.

Ševce Matouše 26

140 00 Praha 4

Czech Republic

tel: +420 737268655

tel: +420 737268695

fax: +420 241405825

e-mail: info@axon-cro.com

www.axon-cro.com

 
 

Broad Therapeutic Expertise

  • Allergy/Immunology
  • Cardiovascular Disease
  • CNS/Neurology
  • Dermatology
  • Diabetology/Endocrinology
  • Gastroenterology
  • Hematology
  • Infectious Disease
  • Oncology
  • Pain Control
  • Psychiatry

... and other

Clients

partial client list ...

References: available
at request

Our Team

  • 26 CRAs
  • 1 AQC Specialist
  • 2 IT Specialists
  • 1 Financial Director
  • 1 Office Manager
  • 1 Regulatory specialist
 

(c) 2009 - Axon-cro