|
|
 |
Our work spans the full spectrum of product registration:
1. Implementation
• Translation of technical documents
• Regulatory compliance (GDP, GMP)
• Liaison with regulatory authorities
• Submission/eSubmission for marketing application
2. Post-Marketing
• Drug safety and pharmacovigilance notifications to regulatory authorities
3. Consultancy/Planning
• Regulatory strategy
• Product classification and registration requirements
• ICH CTD/ACTD formatting and compiling
• Dossier review for conformity
4. Post-Approval
• Marketing authorization transfers
• Labeling updates and harmonization
• Variation e.g. extension of shelf-life, new indications, mergers & acquisition
• Renewals
• Advertisement permit applications |
 |
|
|
|
|
