We are a professional and comprehensive CRO specializing in the R&D, registration, and GMP compliance of durgs and health products. Backed by a skilled technical team and rich project experience, we offer one-stop solutions to support the efficient, economical, and seamless commercialization of pharmaceutical and health product pipelines.
business introduction
1、Drug R&D
R&D of API：process development、quality study
R&D of Generics, Consistency evaluation
R&D of New drugs （Innovative and modified drugs）
2、China Registration
Drug Registration: New Drugs, Generics, and Imported Drugs
Registration of active pharmaceutical ingredients, pharmaceutical excipients, and pharmaceutical packaging materials
Registration of dietary supplements and "new food ingredients, new varieties of food-related products, and new varieties of food additives"
3、China Registration
Drug Registration: New Drugs, Generics, and Imported Drugs
Registration of active pharmaceutical ingredients, pharmaceutical excipients, and pharmaceutical packaging materials
Registration of dietary supplements and "new food ingredients, new varieties of food-related products, and new varieties of food additives"
International Registration
US DMF Registration（Active pharmaceutical ingredients, pharmaceutical excipients, packaging materials）
EU CEP Registration
Registration in Japan/Korea/Canada and other countries
4、GMP Compliance
GMP/Pharmaceutical Quality system establishment/improvement
Audit, validation, training
Drug authorities inspection support
5、Global reference standards and clinical control drug supply——Z&K Pharma
One-stop Service for Domestic & Overseas Licensed Original Drugs and Medical Devices Agency Procurement & Logistics
Support Cross-border Delivery for International Multi-center Clinical Trials
Reverse Export Service for China-marketed Original Research Drugs
6、Global Trade ——Z&K Pharma
Finished Dosage Form (FDF) Export (Focus on Emerging Markets: Southeast Asia, Central Asia, Russia)
API & Reagent Export
Global Supply & Transit Trade of Reference Listed Drugs
