Regulatory Affairs Services

Preparation of Type Variation (Type IA, Type IB, Type II Variation) Dossiers

Preparation of Type Variation (Type IA, Type IB, Type II Variation) Dossiers

Our expert team shall prepare the Type Variation Dossiers in accordance with current regulations and guidelines, and then submit such applications

  • Determining missing documents/requirements of type variation dossiers (Gap Analysis))
  • Determining variation type according to the guidelines
  • Translation of the modules affected by the variation
  • Preparation of the variation dossier in accordance with guideline requirements
  • Submission of electronic applications (upon request of the company)