Development and Registration Veterinary Biologicals & Vaccines

Welcome to Cantum Biosciences, Animal Health Biological Products Development & Registration Consultancy
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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 and analytical development of veterinary vaccines and biological products.
Thierry regularly provides services to research laboratories, start-ups and established animal health companies. He is also a reviewer for the European Commission HORIZON funding programme tackling emergent diseases. He frequently reviews and help research projects submitted to organisations funding the development in LMIC of veterinary vaccines and biological products destined to livestock or to reduce antimicrobial resistance (AMR).
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.
Compliance and reports

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

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
Regulatory affairs

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. 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. All this requires a specific practice and experience to avoid costly issues and delays such as missing or sub-optimal analytical, clinical or validation studies, erroneous development steps sequence or running non-necessary studies.
In vaccine and biological product development, one can't make a silk purse out of a sow's ear. Successful product development 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 will 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 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 also produces the required quality and clinical regulatory documentation needed for your animal health biological product dossier submission including expert reports, assembles the regulatory dossier and follows it through the registration procedure, helping you to respond to regulatory queries within their deadline.
Consultant vaccine development

35 years of biological products expertise in animal health

Veterinary biological and vaccine regulatory affairs
Veterinary vaccine development consultancy

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

Biological product production transfer

Production and quality transfer

Identification & management of all technical and regulatory steps required for biological production and testing site transfer

Vaccine development and regulatory

Technical and regulatory training

All aspects of clinical, manufacturing, quality, validations and registration of veterinary biological products for any animal species

Regulatory compliance

Technical and regulatory compliance

Technical and regulatory gap analysis with corresponding required clinical, manufacturing and quality updates of registered dossier

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