PRE-SUBMISSON ASSESSMENT

Product Evaluation and Classification Assessment

Dossier Assessment and GAP analysis (Document Assessment, etc.)

Strategical Regulatory Advice

National Legislation Interpretation

External Resource/Expert Management

etc.

 

SUBMISSION

Dossier Preparation

Translation Activities

Submission Processes 

Liasion with Health Authorities

Labeling Support

PIL Support,

etc. 

 

POST-AUTHORIZATION ACTIVITIES

Post-Authorisation Maintenance 

Change Control Assessment and Variation Management

Preparation of Responses to Regulatory Agencies Questions

Other Technical Expert Services

Advertising and Promotional Material Review

etc.

 

OTHER ACTIVITIES

Product Analysis Support

Outsourced Regulatory Affairs Department

Training

etc.