Huayi Isotopes Co. (HIC)
Custom synthesis, analytical development and regulatory affairs.
What they do
- Discovery & research
- Development & CMC
- Manufacturing
- Testing & analysis
- Regulatory & quality
From their website
Aboutus
CMOServices
- Custom API (opens in a new tab)
- Validation services (opens in a new tab)
- Transfer services (opens in a new tab)
- Reagent kits (opens in a new tab)
- Cassette assembly (opens in a new tab)
- Clinical trial products (opens in a new tab)
- Batch record development (opens in a new tab)
- Regulatory fitting assistance (opens in a new tab)
- Label/pack/sterilization (opens in a new tab)
- HPLC (opens in a new tab)
- ICP-MS (opens in a new tab)
- GCMS (opens in a new tab)
- LCMS (opens in a new tab)
- NMR (opens in a new tab)
- ICH Stability Testing (opens in a new tab)
Company website
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CMOServices
Company website
Quality & certifications
- FDA cGMP (opens in a new tab)
- ISO 13485 (opens in a new tab)
- CE certificate (opens in a new tab)
- European CE certification (opens in a new tab)
- GMP certification (opens in a new tab)
- FDA DMF number (opens in a new tab)
- GMP quality system (opens in a new tab)
- CE Marked (opens in a new tab)
- DMFs filed with US FDA (opens in a new tab)