From Lab to Livestock: Our Environment, Your products, Our Analysis, Your Solution
Using laboratory and field studies, commercial farm scale trials and environmental risk assessments, our turnkey capability offers an end to end service for product development in the livestock production sector.
Collectively our unique partnership brings more than 60 years of experience in livestock research, trials to GCP and GLP standards and compliance with international regulations in both beef, dairy, poultry, pig and sheep sectors providing a fully end to end solution.
At Fera, the specialist CRO team have a passion for animal health, a strong client focus and a track record for developing and delivering tailored innovative solutions. Their combined facilities offer extensive and flexible Good Laboratory Practice (GLP) accredited facilities suitable for all farm animal species supported by an independently managed Quality Assurance Unit and trained Good Clinical Practice veterinary (GCPv) Study Monitors. The Fera collective team also includes experienced environmental exposure modellers skilled in evaluating the risk of veterinary medicines to the environment, and environmental fate and ecotoxicology specialists with expertise in strategic review, study design, evaluating studies, reviewing literature and bespoke analytical assessment, plus in the field application and assessment and study monitoring support, high level bench science and commercial farm field trials of new product registrations and extended product scoping.
At RAFT, we provide access to a formal network of phenotype farms for trial work and sampling across the country in the beef, dairy, pig and sheep sectors, working with progressive livestock farmers who have been involved in clinical field trials and research programmes for many years and have developed facilities and team structures to support trial work. Ensuring we are very well positioned to undertake field studies we have a proven ability to find suitable sites to meet the requirements of specific projects to GCP standards.
Services in this package include:
- Design of research and development programmes (for the registration of novel veterinary & generics to support desired label claims)
- Design and execution of clinical programmes (efficacy and safety studies, discovery and development) to support desired label claims
- Clinical field trial network and experience
- Experienced project management team & trusted R&D experience
- Study site selection, management and monitoring (field or CRO based)
- Fast track design, conduct and delivery of individual lab/CRO based efficacy studies
- In depth knowledge of the European regulatory process
- Clinical report writing
- Production of clinical expert statement to support regulatory submissions
- 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 drafting technical responses to questions from regulatory agencies
- 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 successful product commercialisation strategies
- Design and delivery of market support studies
- Highly respected and renowned practice based veterinary experts in beef, poultry dairy, pig and sheep
- Radiolabelled livestock adsorption, distribution, metabolism and excretion (ADME) studies
- MRL studies to in support of EU maximum residue limits guidelines