Technical and regulatory solutions to veterinary biological product development
Expertise in veterinary vaccines and biologicals
Dr Thierry Biot is an independent consultant specialised in the technical and regulatory assistance to all aspects of the pre-clinical, clinical, production and testing development of veterinary vaccines and biological products.
Thierry regularly provides services to research laboratories, biotechs and established animal health companies willing to gain a first registration of a novel vaccine or to modify an existing registration licence through a regulatory variation. He is also a project reviewer and monitor for the European Commission HORIZON funding programme tackling emergent diseases and for governmental and non-governmental organisations funding the development of veterinary biological products and the reduction of antimicrobial resistance (AMR) in LMIC.
Based on his 35 years experience of the development and registration of veterinary vaccines and biological products, Thierry helps you to focus on the necessary studies required for proof of concept, development and registration of your veterinary vaccine or biological, saving you time, money and efforts.
Thierry also provides technical and regulatory gap analysis of existing veterinary vaccines and biological products to maintain their competitiveness or compliance to the latest legislation. He takes care of the production and submission of any resulting product licence variations.
Thierry contributed to the creation and launch in 2022 of One Health Pharma, a multidisciplinary team of experts in human health, animal health, and corporate social responsibility (CSR), covering the entire life cycle of medicinal products or services. One Health Pharma offers consulting and training services to companies in the health sector, within an innovative and agile structure, ready to support you with the help of specialised consultants.
Thierry is proud to help the conversion of innovative veterinary vaccine and biological research projects into registered medicines, increasing their global availability and increasing the number of our One Health tools.
Documentation & Training
Preparation of all technical, scientific or regulatory reports, including registration dossier parts and critical reports required. Training in all aspects of biological technical development and registration
Technical development
Proof of concept needs. Clinical, analytical and validations studies required for the intended product claims and compliant to regulatory requirements. Product acquisition and manufacturing transfer
Registration of Biologicals
Preparatory meetings with regulators. Preparation and conduct of regulatory procedure for new products or variations and response to regulatory queries. Regulatory and technical gap analysis
Animal health vaccine and biological products specificity
The development and registration of animal health vaccines and biologicals are carried out through defined technical and regulatory guidelines which details are distinct from those published for veterinary pharmaceutical products or for human health vaccines. The accurate and current interpretation of the veterinary vaccine and biological products legislation is essential. The correct sequence of technical and regulatory development of these products is paramount. Thierry helps you in the early presentation of your candidate product to regulators for its potential classification as Limited Marketing Authorisation which reduces the number or scope of regulatory studies required or for scientific advice requests. All this requires a specific practice and experience to avoid costly deviations such as missing or sub-optimal analytical, clinical or validation studies, erroneous development steps sequence or running non-necessary studies.
A successful development of vaccine and biological products is ingrained in the quality of the candidate proof of concept. Thierry helps you in all aspects of the pre-development phases of your candidate biological product by ensuring that all material, method and studies details provide a smooth transition through development until registration and product launch.
Vaccine development can be costly when putting the cart before the horses or taking side lanes. Thierry routinely defines all the fine details of the clinical, analytical, production and quality development of your biological product candidate, focusing your time and efforts on the generation of only the required information needed for the expected product claims and registration, increasing your ROI, product launch speed and market impact. Thierry produces the required administrative, quality and clinical regulatory documentation needed for your animal health biological product dossier submission including the required expert reports. If desired, Thierry assembles the regulatory dossier and follows it through the registration procedure, helping you to respond to regulatory queries during the procedure within their deadline.
35 years of biological products expertise in animal health
Technical development
Establishing and reviewing biological product proof of concept and all stages of analytical and clinical development & validations
Regulatory affairs
Writing full analytical & clinical dossier parts and critical reviews for new biological product or variation to existing license
Production and quality transfer
Identification & management of all technical and regulatory steps required for biological production and testing site transfer
Technical and regulatory training
All aspects of clinical, manufacturing, quality, validations and registration of veterinary biological products for any animal species
Technical and regulatory compliance
Technical and regulatory gap analysis with corresponding required clinical, manufacturing and quality updates of registered dossier
Contact Info