Services
Successful applications for marketing authorization of vaccines require a strong scientific approach, positioning the product appropriately. A regulatory strategy needs to take this into account.
Buphycon Consultancy offers constructive input in the development of a regulatory strategy. Without a secure regulatory strategy, experimental vaccines are liable to failure at the regulatory assessment stage. Devising a coherent regulatory strategy is not just a matter of knowing guidelines; it requires profound experience as well as an understanding of the science behind the product. We are committed to help our clients find strategies that will be effective and will result in successful applications for marketing authorization.
Our services can be summarized as follows:
- Regulatory advice for Vaccines for Human use
- Regulatory advice for Vaccines for Veterinary use
- Regulatory advice for Adjuvants for Human use
- Regulatory Counseling for Adjuvants for Veterinary use
- Scientific advice for Vaccine Development
- Scientific advice for Adjuvants Development
- Scientific advice for Fish Vaccine Development
- Pre-clinical Experimental Design
- Writing Protocols for the Animal and Human Ethical Committee
- Review of Protocols, Reports and Manuscripts
Our team’s combination of experience and network of contacts within the academic, biotechnology, and pharmaceuticals industry means that we are able to identify and recommend experts either to work with our in-house staff on your project, or to address any additional needs, for example in the following areas:
- Provide Expert Solutions to Regulatory Agency Queries
- Manufacturing Process Validation
- Compilation of an entire submission
- Advise on Biological / Virological Safety Questions
- Development of Appropriate Read-out Systems
- Diagnostics
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