WHAT WE DO - BIOVIPE | We provide expertise for conjugate vaccines, pediatric vaccines, viral vaccines and influenza vaccines.

We provide scientific, technical and operational consulting services to vaccine manufacturers on a wide range of strategic aspects of vaccine development such as:

1

Early development with a Quality by Design (QbD) approach
Process development
Process scale - up to final scale production

2

Transfer of the process in a manufacturing facility including assessment of the GMP compliance (Tech-Transfer)
Development and validation of dedicated analytical methods

3

ICH-GCP compliant clinical development
Support on Clinical Trial Application (CTA) including writing - up of study protocols, supervise clinical operations, writing CSR and other relevant documents.
Medical writing

4

Development of human serology assays

5

Writing - up of non-clinical and clinical technical regulatory documents for MMA
Writing - up of the regulatory dossier (CTD,WHO PQ)

6

Medical affairs
Business development
Governmental affairs

We provide expertise for conjugate vaccines, pediatric vaccines, viral vaccines including polio, MMR and influenza vaccines

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