FULL SERVICES VET CONTRACT RESEARCH ORGANISATION

We support the process for your product from the idea to marketing authorization:

  • Pre-clinical and clinical development plans,
  • Site selection, laboratory identification and management,
  • Conducting proof-of-concept studies, pilot and pivotal studies,
  • VICH GCP clinical studies standards.

ON-GOING PIVOTAL STUDIES

  • Undisclosed partner – 110 Dogs patients – Oncology (from September 2015 to December 2016)

ON-GOING PILOT STUDIES

  • Undisclosed Biotech partner – 30 Dogs – Osteoarthritis
  • Undisclosed Biotech partner – 40 Dogs – Solid Tumors
  • Undisclosed Biotech partner – 40 Dogs – Atopic Dermatitis

REGULATORY AFFAIRS KNOW-HOW

  • Pharmaceuticals
  • Immunologicals
  • Biologicals

REGULATORY STRATEGIES

  • MUMS (Minor use-minor species) products
  • Innovative products

REGULATORY DOCUMENTATION
& SUBMISSION PROCESS

  • Compliance check of labels and product material
  • Expert Reports
  • MUMS applications
  • Marketing authorisation dossiers – complete or in parts, full or abbreviated
  • Electronic and/ or paper based submissions
  • Back/Forth questions with agencies
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