• |

Regulatory Services

• Feasibility study of planned registrations
• Economic regulatory strategies
• Full regulatory project management
• Selection and coordination of external partners and CROs
• Dossier development
• Management of application procedures
• VNeeS format and electronic submission via CESP or Eudralink
• Coordination of the national phase
• Full life-cycle management

Scientific Services

• User safety assessment
• Environmental risk evaluation
• Consumer safety assessment
• Bioequivalence including bio-waivers, in-vitro or in-vivo studies.

Our dedicated network of professionals provides all required additional scientific disciplines and services. You get a single-source solution from a highly efficient team put together especially for your project.

Pharmacovigilance

QPPV and Deputy QPPV services
• Establishment and maintenance of pharmacovigilance systems
• Veterinary medical assessment
• Electronic reporting of adverse event reports via EVvet
PSUR research and writing