Veterinary products

Product scope

We assess the applicable route and evidence requirements for each product category.

• Veterinary medicines, immunological products and vaccines.
• Feeds and feed additives, including GMO-related products.
• Animal care products, disinfectants and antiseptics.
• Diagnostic kits, veterinary equipment and devices.

Dossiers and regulatory procedures

We audit the data, develop the strategy and documents, and manage filing and authority interaction.

• Veterinary medicine registration in Russia and the EAEU.
• Dossier alignment with EAEU rules, registration confirmation and changes.
• Feed additives: data review, literature reviews and reports, sample testing and procedure management.
• Responses to questions, translation, notarisation and sample importation.

Development and studies

We design the evidence programme and support its implementation.

• Programme development and review, and methodology.
• Selection and set-up of centres and farms, oversight and monitoring.
• Project and data management, biostatistics and reporting.
• Deposition of pathogen and virus strains with culture collections.

Quality, manufacturing and circulation

We help prepare the systems and processes required by the project.

• Gap assessment, quality systems, SOPs and procedures.
• Equipment and process qualification and validation.
• GMP inspection preparation and support, CAPA and regulator findings.
• Licensing, GDP/GSP, storage and distribution, Authorised Person services and market release support.

Pharmacovigilance and ongoing support

We prepare safety reports, process cases, support regulatory activities and work with relevant information systems. Training covers GMP, manufacturing and documentation. Services are available as a complete project or individual assignments.