VET INDUSTRY

Full services vet contract research organisation

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

1. Pre-clinical and clinical development plans

2. Site selection, laboratory identification and management

3. Conducting proof-of-concept studies, pilot and pivotal studies

4. VICH GCP clinical studies standards

ON-GOING PIVOTAL STUDIES

Undisclosed partner – 110 Dogs patients – Oncology

ON-GOING PILOT STUDIES

Undisclosed Biotech partner – 30 Dogs patients – Osteoarthritis

Undisclosed Biotech partner – 40 Dogs patients – Solid Tumors

Undisclosed Biotech partner – 40 Dogs patients – 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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