Regulatory Affairs
We support our clients to overcome regulatory hurdles from initial development to product commercialization as we have a Strong expertise in pharmaceuticals FDA and/or European Dossiers, requirements for the development of new products, assessment & update of existing dossiers and Substance Master Files and full response to Agencies' question.
Regulatory Affairs Management include
- Central EC/IRB Preparation , Submission and Approval
- Central EC/IRB Amendments (For Preparation And Submission), Submission and Approval
- Local EC/IRB Preparation , Submission and Approval, Submission and Approval
- Local EC/IRB Amendments (For Preparation And Submission), Submission and Approval
- Competent Regulatory Authority (CA) Preparation/Notification (For Observational Study), Submission and Approval
- Competent Regulatory Authority Submission (For Interventional Study), Submission and Approval
- Competent Regulatory Authority Amendments (For Preparation And Submission), Submission and Approval
- Adapt Amended Informed Consent Form To Country Requirements Or Amended Country ICF To Site Requirements, Submission and Approval