As part of the business expansion plan for medicinal products and medical devices, China offers enormous business opportunities as the Regulatory bodies in the region are being harmonized with that of the international standards. To get the market access, manufacturers must obtain approvals from National Medical Products Administration (NMPA) (formerly known as China Food and Drug Administration [CFDA]). However, the more the processes are being harmonized the stringent and complex they are becoming. Navigating through updated regional Regulatory regime might be challenging for foreign manufacturers.
With the specialized Regulatory affairs consulting, right from the document preparation to NMPA registration, obtaining market authorizations to renewing licenses, decoding Regulatory pathways to building up strategies, Freyr’s assists manufacturers to reduce the drug/device’s time to market. Freyr's Regulatory services in China span across:
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- Compilation and Submission of Technical Construction File
- Drafting and filing dossiers as per CTD format
- Toxicology Safety Assessment
- Label/Ingredient Review
- Strategic and well-versed local regulatory knowledgebase – with NMPA, MOH.
- Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines