Preparation and audit of the registration dossier
Preparing the registration dossier is a fundamental step in bringing veterinary medicinal products and feed additives to the EAEU market. The dossier is a detailed scientific and technical justification of the quality, safety and efficacy of the product. Errors, missing reports or an incorrect structure delay the review and lead to the authorities refusing to issue a registration certificate.
Dossier structure
A structured registration dossier for a medicinal product consists of several interrelated sections:
- Administrative part: the manufacturer's legal documents, licences, GMP certificates, packaging mock-ups and the official instructions for use.
- Quality and pharmaceutical properties: the chemical structure of the active molecule, raw material specifications, a description of the manufacturing process and stability data.
- Preclinical safety: detailed reports on toxicology, pharmacokinetics, pharmacodynamics and specific activity.
- Clinical evidence: results of therapeutic and zootechnical efficacy studies in target animal groups and justification of withdrawal periods for residues in food of animal origin.
Expert preparation of each module minimises the number of comments during the state review.
Why work with us
- In-house testing facilities: a large fleet of high-precision equipment allows us to quickly carry out missing tests and update the dossier with additional reports.
- Extensive practical experience: more than 10,000 completed studies give us a deep understanding of how Rosselkhoznadzor experts assess a dossier.
- Audit at the start: reviewing the existing materials prevents losses from submitting an incomplete package.
How we work
- A comprehensive audit of the client's materials and a gap map of missing documents.
- Development of technical and regulatory documentation, specifications and quality control documents.
- Organisation and oversight of any missing preclinical and clinical tests.
- Final assembly of the dossier, formatting to current EAEU standards and handover to the client for submission.
Cost
The cost of preparing a registration dossier is calculated individually based on the materials provided. It depends on the type of product (original molecule, generic or feed additive), the extent of missing study data and the complexity of the analytical control methods. For an accurate estimate, send us a list of the documents you have.
How to order
To get a quote and agree on the study design, contact Neurometrix specialists by phone at +7 903 613-00-79 or send a request to info@neirometrix.ru. We prepare a commercial proposal within two business days.