The requirements to the documentation for the registration of veterinary medicinal products have been tightened over the years and are now as strict as for human medicinal products.
As each species must have its own clinical coverage and animals for human consumption must be covered for MRL (maximum residue level), the requirements are even stricter in some respects.
We have dealt with new products as well as with generics covering veterinary vaccines, veterinary pharmaceuticals, animal feed, food supplements and biocides.
We have many years of experience with applications for the registration of veterinary medicinal products both by the national procedure and by the MRP and DCP.
The CTD format is not applicable for veterinary medicinal products and the Notice to Applicants format is still in use.
The electronic format VNeeS has been development and is already in use in many of the procedures and in most countries. We can also assist with electronic submissions as we have the necessary software in house.
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
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