Services

Development Project Design & Execution

• 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 Shooting

• 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 & Studies

• 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

Registration

• 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

Commercialisation

• 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