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Consultancy
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Advice and design of protocols for :
- pre-clinical trials for veterinary medicinal products
- clinical trials for veterinary medicinal products
- trials for veterinary products: biocides, antiseptics, additional feeds,
additives in feedingstuffs, new drugs delivery systems, etc.
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Regulatory affairs
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Preparation of all parts of the Marketing Authorization Application files for
pharmaceutical and non pharmaceutical veterinary products.
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Pharmacovigilance
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Writing of Periodic Safety Update Reports (PSUR's).
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Performance of trials
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Pre-clinical trials for veterinary medicinal products.
Bioequivalence, PK and residue studies.
Clinical field trials for veterinary medicinal products.
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 Studies are conducted in GCP
conditions, with an European network of veterinarians.
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Studies of efficacy and tolerance for veterinary products: biocides,
antiseptics, additional feeds, additives in feedingstuffs, new drugs
delivery systems, etc.
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 Studies are conducted in
collaboration with universities and private laboratories
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Animals
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Domestic species :
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cattle - pigs - sheeps - horses - dogs - cats - poultry - fishes - new
companion animals
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Laboratory species :
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mice - rats - hamsters - guinea pigs - rabbits - dogs - cats
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Writing of scientific reports
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Statistical analysis of data, in collaboration with biostatisticians.
Assessment and writing of registration files for pharmaceutical (parts II, III, IV
- CTD format) and non-pharmaceutical products.
Original data can be generated by Pharnimal or provided by the applicant.
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Expert reports
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Critical assessment or registration files for pharmaceutical and non-pharmaceutical
products by qualified experts.
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