Xihua Scientific

Bioanalytical Services

Over 400 methods for generic drugs ;  MD/MV & sample analysis for BE studies and FIH studies with quick turn-around time ;  PK & BE statistics analysis; > 95% method using stable isotope labeled internal standard; Over 100 domestic clients.;  Partnership with tier-1 hospitals, clinical CRO around the country;  MD/MV for LM drug PK, ADA, and Nab assays and biomarkers ;  Reagent production & labelling;  Sample analysis for clinical trials for biosimilars and innovative drugs;  Method developed for 20 popular biosimilars;PK statistics analysis;

Clinical Services

JV with Li-Ou Clinical Services Inc. Ltd.;  1 dedicated site for Xihua;  Partnership with 8 clinical CROs and over 20 clinical sites;  BE pilot and pivotal studies;  FIH trial for innovative drugs;  PK and BE statistics analysis

Consulting Services

Training classes on regulated bioanalysis in collaboration with CFDA;  For scientist: Regulation, instrument & LIMS operation, documentationFor QA & management: study management, inspection, deviation reporting and remediation ;   offered by Xihua senior management;  Classes approved & certificate issued by CFDA;  Fit-for-purpose training at client’s site;  On-site inspection on bioanalytical and clinical studies before regulatory agency audit;  Domestic mainland studies;  India/US/Canada/Taiwan studies;  On-site consultation for formulation commercial production

Xihua Pharma

CMC Services

Formulation development;  Packing material compatibility test;  Regulatory filing;  Clinical material manufacturing;  Analytical development;  Product release test

Primera Analytical Solutions Corp

Highly experienced with China and US/EU regulations;  One-stop shop for drug late phase development;  China/US operations;  Data qualified for global filing