Regulatory Affairs
EGeen regulatory affairs services provide critically accurate review, submission and approval capabilities from both beginning to end of the clinical trial. From national and regulatory body relationships to proper filings, EGeen ensures that the value capture of the clinical trial data results in positive product outcomes and approvals.
Regulatory Relationships
- Ethics committee interactions, relationships
- Regulatory approval requirements
- National authorities relationships
- Data submissions to regulatory authorities
Investigational Product Importation
- Product registration
- Product importation and shipping logistics
Pharmacovigilance
- SAE reporting, audits
Regulatory Administration
- Document translations
- Submission file design and compilation