Expertise

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As one of the few veterinary CROs Regivet BV has a fully equipped pharmaceutical development laboratory, enabling us – together with external partners – to offer the complete development package for veterinary pharmaceuticals, starting from a basic product idea up to a national or a European product authorisation.

We have experience in the development of different formulations, such as tablets, powders, injection fluids (solutions and suspensions), intramammary and topical products. Furthermore, Regivet BV has two large climate chambers on site for new and ongoing stability studies.

Standards

We work according to GMP and VICH GCP standards.
In July 2018 the Medicines Evaluation Board – Veterinary Medicinal Products Unit issued a Certificate of GMP Compliance for Regivet: Certificate No: NL/V 18/0011. The authenticity of this certificate may be verified in EudraGMP.

Partners

Regivet BV has built a strong network of external partners specialised in contract manufacturing, API development, bioanalysis, in-life studies etc.

Our expertise

Generic
applications

Updates of
existing dossiers

New full
applications

Detailed and Critical Summaries

Acting as applicant or assistance before and during application

Monitoring and second opinion

ASMF/CEP
evaluation

Laboratory
services