Clinical Expertise for the
Development and Registration
of your Veterinary Medicines
To find out more about how VRM
is working with Cyton to provide
a complete clinical service, please
visit the website:
Which target species are your products designed to treat? For which indications will your products be used? These are questions which will be answered by the data in your preclinical and clinical package and will determine the commercial success of your products. Cyton’s qualified veterinarians have extensive experience in regulatory affairs and can ensure that you generate the right data to support the commercial requirements of your product.
As experts in preclinical and clinical development, Cyton's team will advise you on the likely regulatory success of your product, before you commit to expensive studies and regulatory submissions.
Where current guidelines do not fully apply to your products, for example with novel therapies, you can be confident that Cyton’s regulatory veterinarians will fully justify any deviations and will stand by their principles, ready to challenge the competent authorities when necessary.
Cyton provides regulatory support for our clients at all times during the product lifecycle: throughout the product development phase; during preparation of the technical dossiers for regulatory submissions; in defense of products when responding to questions from the regulatory authorities.
Dossier preparation, submission and regulatory procedures
In vivo bioequivalence / clinical equivalence