Veterinary biological product consultancy - Veterinary vaccines development and registration

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Veterinary biological product consultancy

Veterinary vaccine development and registration

Veterinary biological regulatory affairs
Technical regulatory dossier

Production of the analytical dossier required for the EU deliberate release authorisation of a recombinant vaccine for poultry
Clinical safety & efficacy study reports review and summary for a new recombinant multivalent poultry vaccine
Analytical technical review and expert reports on new GMO vaccines destined to livestock animals
Technical summaries and expert report on various type II analytical variations covering among others bioreactor production process conversion, inactivation method or potency test of vaccines destined to poultry, dogs, cattle and swine
Increasing veterinary vaccines accessibility
Vaccine availability

Expert to the Livestock Vaccines Innovation Fund (LVIF) which is an initiative developed by the Bill and Melinda Gates Foundation, Global Affairs Canada and the International Development Research Center (IDRC) based in Ottawa. LVIF represents a joint investment of CA$57 millions over seven years to support the development, production and commercialization of innovative vaccines against livestock neglected diseases in sub-Saharan Africa and South Asia
Regular technical review of over 30 vaccine development projects submitted for fund application by various research Institutes worldwide
Helping IDRC funded projects by visits to research and vaccine development sites in Africa for technical discussion and assistance
Veterinary biological products transfer activities





Antigen manufacturing transfer

Identification and management of all the technical and regulatory steps required to transfer the production of an existing recombinant antigen produced in Baculovirus to a new manufacturer, including adaptation to bioreactor and volume scale-up
Veterinary products compliance & gap analysis




Technical and regulatory compliance

Assessment of technical and regulatory compliance of registered dossiers for entire product portfolios of a large veterinary products manufacturer covering EU, USA, Japan, Russia, Canada, Africa, South America and Asia
Veterinary vaccines acquisition



Veterinary vaccine acquisition

Visit of a veterinary vaccine producer in South America for an extended technical review and reporting on their facilities, products and activities in preparation to a Due Diligence
Veterinary diagnostic kits


Veterinary diagnostic kit development

Contribution to the technical re-development of an existing veterinary diagnostic kit to enhance its sensitivity and specificity
Technical and regulatory contributions to various manufacturing site transfers of diagnostic kits from Europe to US and within USA
Veterinary vaccine development and registration



Vaccine analytical development training
 
Vaccine potency test training for the R&D department of a large veterinary manufacturer in South America covering in vitro and in vivo potency tests for live, recombinant and inactivated vaccines. Emphasis on solutions to move from in vivo to in vitro potency tests
This training resulted in a request from the Company to help devise the potency test of two of their vaccines under development
Veterinary products and One Health



One health

Since January 2022, veterinary regulatory expert in the multidisciplinary team of OneHealth Pharma, contributing to the construction of the human and animal health integrated approach, key element of our future
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