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Pesticides
GAB consulting offers services in product registration and regulatory affairs of veterinary vaccines and pharmaceuticals according to the requirements of Directive 2001/82/EC as amended and the latest EMA and VICH guidelines. This includes scientific and regulatory support during all stages of product development from the initial check of feasibility to the final approval of your veterinary medicinal product. Our experts guide you through the regulatory requirements and assist you with the appropriate regulatory approach, studies, dossier preparation, submission and post-submission support. GAB works together with experienced laboratories and contract investigators to ensure development of your vaccine or pharmaceutical product according to latest regulatory requirements.
  • Project plan and project management
  • Pre-clinical and clinical development
  • VICH-Environmental Risk Assessment
  • Organisation of Contract Research
  • Study management and monitoring (safety, efficacy, laboratory and field trials)
  • Writing of registration dossiers
  • Critical summaries of dossier/expert statements
  • Variations, extensions and renewals
  • Electronic Data Management
  • Regulatory update
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