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Development Project Design & ExecutionDevelopment programme design to support veterinary medicine registrations

  • Design of research & development programmes for the registration of novel and generic products to support desired label claims
  • Management and coordination of existing development projects or of component parts for sponsors
  • Assembly and coordination of global teams of in-house and external experts to ensure on time and on budget delivery of registration dossiers
  • Vendor management identifying and managing external resources to deliver component parts of project plans on time and on budget

Project Trouble ShootingSpeeding up veterinary clinical development programmes

  • Identification of critical path activities to accelerate projects and allow contingency planning to ensure on time registration
  • Identification and management of external facilities and expertise to fill client resource gaps
  • Production of detailed project plans to actively manage resources identifying and resolving resource constraints

Clinical Programmes & StudiesDelivery of veteriary clinical studies programmes

  • Design and execution of clinical programmes (efficacy and safety studies, discovery and development) to support desired label claims
  • Expert advice on study design
  • Study site selection, management and monitoring (field or CRO-based)
  • Fast track design, conduct and delivery of individual laboratory / CRO-based efficacy studies
  • Direct access to leading CROs in the northern and southern hemispheres, for the conduct of animal studies in pen or at pasture, including efficacy, safety, pharmacokinetics, residues, feed additives
  • Fast tracking of clinical programmes, by year-round conduct of seasonal studies
  • Parasite sourcing and supply
  • Model development work
  • Specialist Parasitology & Bacteriology facilities

RegistrationEuropean registration experience – centralised, decentralised & national

  • In-depth knowledge of national and the European regulatory process
  • Consultation with national and the European Regulatory Agencies to develop appropriate registration strategies
  • Clinical report writing
  • Production of Clinical Expert Statements to support regulatory submissions - in-depth parasiticide expertise and access to a wide range of world renowned experts in other disciplines
  • Coordination of the assembly and submission of regulatory dossiers and the response to questions to minimise delays and ensure on-time product approval
  • Preparation of data and the drafting of technical responses to questions from regulatory agencies

CommercialisationPlans to convert veterinary clinical development data into commercial messages

  • Design and delivery of technical transfer packages and publication strategies to support successful product commercialisation
  • Writing of technical manuals, practitioner information and scientific papers to support product commercialisation strategies
  • Design and delivery of market support studies