Regulatory Affairs
Global regulatory strategy and submission services for successful drug approvals
Regulatory Excellence
Oracle BioTech's regulatory affairs team provides strategic guidance and comprehensive submission services across global markets, ensuring successful navigation of complex regulatory pathways.
Global Regulatory Strategy
Comprehensive regulatory strategy development for global markets including FDA, EMA, and other health authorities worldwide.
- Regulatory pathway planning
- FDA breakthrough designation
- Orphan drug designation
- Pediatric investigation plans
Submission Services
End-to-end regulatory submission services from IND through NDA/BLA with expert regulatory writing and project management.
- IND/CTA submissions
- NDA/BLA preparation
- Post-marketing commitments
- Regulatory correspondence
Regulatory Process
Strategy
PlanningRegulatory strategy development and pathway selection.
IND/CTA
SubmissionInvestigational new drug application preparation.
Development
SupportOngoing regulatory support during clinical development.
NDA/BLA
ApprovalNew drug application and biologics license application.
Post-Market
CompliancePost-marketing regulatory compliance and lifecycle management.