Freyr Expertise
- Pharmaceutical Regulatory Services & Consulting Solutions in China.
- End-to-end Regulatory Support for the Medicinal Product/Drug Registration in China till Approval from the National Medical Products Administration (NMPA).
- Local Representative Support and Pharmaceutical Regulatory Affairs in China.
- Support with Pre-application Meetings with NMPA/Liaison with HA until Approval.
- Business Strategy and Regulatory Market Consultation.
- Registration Category, Application Type, and Classification.
- eCTD Publishing and Submissions.
- Support for Translation Services.
- Regulatory Intelligence Support.
- IND Application Support in China
- Lifecycle Management of Post-approval services- Periodic Safety Reports, Benefit-Risk Reports (PBRERs, PSURs), post-approval change management, annual report submission etc.
- Regulatory Software Solutions.
