Sample Requirements - input of users

The user might have to provide the master study documents necessary for the opinion/advice/submission.

Lead Scientist

Hilde Depraetere, PhD

Description of service

The EVI regulatory service is available to guide you to build your regulatory plan, particularly for vaccines for which clear regulatory guidance may not be available to you. Early assessment of the potential regulatory requirements may prevent unnecessary project delays and reduce extra costs.

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EVI range of services include:

·        Expert opinion support

·        Support to prepare for a Scientific Advice meeting with EMA or National regulatory Agencies (NRA’s)

·        Support with pre-clinical and clinical development plan

·        Regulatory intelligence: Support to assemble relevant regulatory requirements, guidelines and legislations regarding vaccine development.

·        Support to prepare Investigator’s brochure and or IMPD