SERVICES
MEDICAL DEVICES

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

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

Product Movement Notifications

Pharmacovigilance Activities (Field Action Reports, Manufcaturer's Reports, Recall Actions, etc)

Advertising and Promotional Material Review

etc.

 

OTHER ACTIVITIES

Registration Holder Services

Pharmacovigilance Services

Reimbursement Submissions and Management

Outsourced Regulatory Affairs Department

Training

etc.