KRB金瑞博 offer service "Regulatory affairs services"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
Regulatory affairs services
Details
Specifications
- Service Category: Regulatory affairs and clinical supply support services.
- Regulatory Certification: Specific accreditations are not itemized in the listing; advisory, analytical, or process work of this kind is typically carried out in line with ICH, GMP, and regional regulatory (FDA/EMA) frameworks.
- Capacity Scale: Project scale is not itemized in the listing; teams offering this kind of advisory/analytical/process service typically flex to handle multiple concurrent client engagements of varying scope.
- Geographic Coverage: Specific export markets are not itemized in the listing; the supplier serves international B2B pharmaceutical buyers on a project/inquiry basis rather than a fixed regional list.
- Lead Time: Project timelines are scoped per engagement; typical assignments run from a few weeks for focused advisory/analytical work to several months for larger regulatory or process-development programmes.
Other Information
Additional Description:
This provider manages ANDA, NDA, and IND submissions to China's NMPA end-to-end—covering gap analysis, compilation, submission, sample testing, CDE review tracking, and supplemental materials—alongside pre-submission gap analysis and strategy, pre-IND/NDA CDE meeting support, and filing and technical review of APIs, excipients, and packaging components. Its consultants bring over a decade of drug-registration experience, having secured 30+ imported drug registration certificates, 7+ Phase III approvals for an innovator, 5+ Phase I approvals for a domestic biosimilar, and 10+ clinical trial approvals for imported new drugs, supported by more than five former CDE experts.
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