We provide bioanalysis plans for every bioanalytical study and conduct protocol, in-process and reporting phase QA audits for every GLP/GCP project. Method validations and GLP/GCP sample bioanalysis are performed in accordance with applicable USFDA, CFDA and EMA regulations and guidelines.
Our PK specialist can conduct pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies. We perform either model dependent (compartmental) or model independent (noncompartmental) analyses using validated Phoenix WinNonlin software to calculate bioequivalence, drug exposure, and drug recovery data. We will also provide assessments of PK/PD relationships.
MicroConstants China shares the same SOPs, LIMS, and quality system as MicroConstants, Inc. in San Diego. Data generated from our laboratory in Beijing has been accepted by relevant regulatory authorities for IND and/or NDA approval.