Registration of Domestic/Imported Pharmaceutical Excipients and Packaging materials
Classification & Quantity
Pharmaceutical excipients
Ordinary excipients, high-risk excipients, special excipients,
chemical synthesis/natural excipients, premix/blend/multi-component/polymer excipients, etc.
Pharmaceutical packaging materials
Packaging components, packaging systems, complex products,
including prefilled syringes, halogenated butyl rubber stoppers, nasal spray pumps, bottles for eye drops, etc.
Our services include but are not limited to:
Clarification of registration classification;
Reasonability analysis of formula/manufacturing process;
Gap analysis between specifications and ChP&YBB standards;
Guide stability research and compatibility research;
Search of domestic and foreign literature and compilation of pharmacologic and toxicologic research materials;
YBB compliance testing services for imported pharmaceutical packaging materials.
Registration of Special Products
Approved experience of Xizimed
DMFs filing of media
DMFs filing of enzymes
Application for nuclide products
Registration of vaccine adjuvants
