Services do NOT include

Kindly contact the service provider for specific details.

Possible Output

Will depend on the specific service requested.

Sample Requirements - input of users

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

Regulatory support - EVI

Free 

Lead Scientist

Hilde Depraetere, PhD

Timeline 

Timelines according to contract.

Contact 

Hilde Depraetere

hilde.depraetere@euvaccine.eu

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.

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