Clinical Expertise for the Development and Registration of your Veterinary Medicines

With veterinarians and regulatory professionals in Cyton's UK and German offices, our team combines strategic and technical expertise to deliver a complete range of services supporting the pre-clinical and clinical development of our clients' animal health products.

Preclinical and clinical expertise for development and registration of veterinary medicines

Clinical Data for Commercial Success

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.

Regulatory Support and Submissions for Animal Health Products

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.

Summary of our services for preclinical and clinical projects

Product Development Services

  • Development project strategy, design & execution
  • Preclinical / clinical programme and study design
    • Pharmacokinetics and pharmacodynamics, including PK/PD analysis
    • Dose titration / determination
    • Target animal safety
    • In vivo bioequivalence / clinical equivalence (find out more here)
    • Clinical / field trials
    • Target animal challenge studies for vaccines
  • Ready access to leading international CROs and fast tracking clinical programmes by year round conduct of seasonal studies
  • Assembling multidisciplinary development teams
  • Sourcing and managing external facilities and expertise to fill sponsor resource gaps

Regulatory Support, Strategy and Submissions

  • Data audits, gap analysis and literature reviews
  • Technical writing including expert reports or Detailed & Critical Summaries (DACS) and responses to questions (find out more here)
  • Preparation of requests for Scientific Advice and Innovation Task Force briefing documents
  • Coordinating the regulatory submission and approval process for product registrations
  • Support for line extensions and MUMS applications with reduced data sets
  • Assessment of potential for development of antimicrobial resistance


Related pages

Dossier preparation, submission and regulatory procedures

Veterinary Immunologicals

In vivo bioequivalence / clinical equivalence


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
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