orion  
home
about us
experience
   - clinical research & project management
   - clinical development planning
   - regulatory affairs
   - medical writing
   - quality assurance
   - pharmacovigilance

   -

biometrics
products and treatment types
careers
contact us
orion news

Services | Regulatory Affairs

Our regulatory experts possess an astounding wealth of knowledge, enabling us to offer quality regulatory and clinical development services for the pharmaceutical and biotech industries.

Our services include:

  • Preparation of clinical trial applications (CTA, IND)
  • Common Technical Document preparation (CTD)
  • IMPD (Investigational Medicinal Product Dossier) and Orphan Drug Applications
  • Clinical development plans and strategic consultancy
  • Fast Track applications
  • Interaction with gene therapy, viral and environmental committees (RAC, GTAC, CGB, CGO, VSC)
  • Preparation of product licence applications (NDA, MAA)

 

 
© 2005 All rights reserved | Privacy Statement | Legal Disclaimer | Design by djm digital solutions