PRE-SUBMISSON ASSESSMENT

Product and Formulation Assessment

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

Strategical Regulatory Advice

National Legislation Interpretation

External Resource/Expert Management

UTS Company Registration Support

etc.

 

SUBMISSION

Document Registration Activities

Product Registration Activities

Labeling Support

IFU/DFU Support

Liasion with Health Authorities

Translation Services

etc

 

POST-AUTHORIZATION ACTIVITIES

Post-Authorisation UTS Maintenance 

Change Control Assessment and Registration Amendments (Documents, Products, Etc.)

Preparation of Responses to Regulatory Agencies Questions

Other Technical Expert Services

Labeling Amendments

IFU/DFU Amendments

Advertising and Promotional Material Review

etc.

 

OTHER ACTIVITIES

Registration Holder Services

Outsourced Regulatory Affairs Department

Training

etc.