• eCTD
• Abridged Applications
• National Procedures
• Mutual Recognition
• Decentralised Procedure
• Variations
• Renewals
• Paediatric Investigation Plans (PIPs) and
  Paediatric Use Marketing Authorisations(PUMAs)
• Certificates of Suitability
• Biostudy Management
• Regulatory Strategy
• Pharmacovigilance
• Compliance
• Herbal Medicinal Products
• Training
• Veterinary Medicinal Products
• Project Management

Electronic Common Technical Document (eCTD)

• With eCTD fast becoming the submission vehicle of choice, Ivowen Limited can provide a full eCTD service for your company.
• eCTD is the electronic version of the Common Technical Document format that is obligatory in the EU. eCTD itself is not yet obligatory but some national Health Authorities and the EMEA are already accepting full eCTD dossiers – often with reduced fees.
• Ivowen Limited has the following capabilities:
  • Extedo eCTD Manager software – fully ICH compliant and also used by EU Health Authorities.
  • Preparation of fully eCTD compliant dossiers prepared from either electronic or paper source files.
  • Preparation of fully NeeS compliant dossiers prepared from either electronic or paper source files.

Contact us for more information.