Consultant veterinary vaccines development and registration
Converting veterinary research into registered medicines
Veterinary vaccines have gained a lot of importance since Louis Pasteur created the first animal vaccine against chicken cholera in 1879. They are nowadays the most cost effective and sustainable methods of controlling animal infectious diseases. They are important regulated tools for the health and well-being of individual animals, but they can also have a huge impact on human health through the control of zoonosis. This development through the One Health approach is still in its infancy, but Cantum Biosciences proudly contributes to this effort.
Cantum Biosciences supports Research Laboratories, Charitable Organisations and Animal Health Companies in their vaccine proof of concept to fill existing gaps in veterinary vaccine availability and to increase our global One Health tools. We take the candidate vaccine through the analytical and clinical development focusing our client's time and efforts towards the generation of necessary-only information, and producing the documentation required for vaccine registration. We write registration dossiers and guide our clients until the conclusion of the registration procedure.In short, we proudly help you convert biological research projects into registered medicines.
Technical development
Pre-clinical development needs. Clinical, analytical and validations studies designed for the final product and matching regulatory requirements. Product acquisition and transfer
Documentation & Training
Preparation of all technical, scientific or regulatory documents, including regulatory dossier parts and critical reports. Training in biological development and regulatory affairs
Regulatory Affairs
Full support of the selected regulatory procedure for new products dossier, licence variations and response to queries within deadline. Regulatory and technical gap analysis
Technical and regulatory support for veterinary vaccines
Start on the right development path. Avoid unnecessary studies and expenses. I help you define the development and validation studies required for the intended purpose, guiding your veterinary biological product development and registration path to maximise your product claim, your effort and speed to market.
30 years of veterinary vaccine development & registration experience
Regulatory affairs
Writing full analytical & clinical dossier parts and critical reviews for new biological product or for variation to existing product license
Technical development
Establishing and reviewing biological product proof of concept and all stages of development, for all animal species
Manufacturing transfer
Identification and management of technical and regulatory steps required for biological product manufacturing site transfer
Technical and regulatory compliance
Gap analysis and technical/regulatory update of registered dossier
Diagnostic kit development
Contribution to re-development of existing veterinary test kits
Technical and regulatory training
Clinical & analytical methods and regulatory training for all types of veterinary biologicals
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