Microconstants China was founded in 2007 by Dr. Gilbert Lam, Founder of MicroConstants., Inc. of San Diego, USA. It is a full service clinical contract research organization (CRO) following global quality standards to provide pharmacokinetic (PK) bioanalysis and early stage clinical trial one-stop full services for domestic and international pharmaceutical and biotech companies for their drug registration in China and abroad.
Located in beautiful San Diego, California as a DMPK/bioanalysis specialty CRO, MicroConstants Inc. was founded in1998 with 34,000 sf laboratory and office space. With over 100 employees, 20+ LC/MS/MS, several MSD systems, MicroConstants San Diego has served over 500 medium and small biotech companies worldwide for their small molecules, large molecules and peptide bioanalysis needs. It passed FDA inspections 4 times without 483.
MicroConstants China is the first OECD-GLP compliant bioanalytical service provider in China with 10 LC/MS/MS and 1 MSD system. Our Bioanalytical Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins and peptides using LC/MS/MS, HPLC/UV, and ELISA/MSD detection. We have experience analyzing API and metabolites in diverse biological matrices and can provide bioanalytical support throughout all stages of preclinical and clinical development, including PK/TK studies, BE/BA studies, tissue distribution studies, and drug-drug/drug-food interaction studies. Method validations and GLP/GCP sample bioanalysis are performed in accordance with applicable USFDA, China NMPA and EMA regulations and guidelines. Our PK lab has passed numerous CFDI inspections for many new drugs and generics drugs with no project withdraw during the 7.22 clinical trial data self-inspection.
Since year 2009, MicroConstants China has been implementing ICH GCP at clinical sites in China, such as No. 307 Hospital and No. 301 Hospital of PLA, Shanghai Mental Health Center, Guangzhou TCM Hospital, etc. and established network of clinical trial centers who are certified by China NMPA to conduct Phase I safety/tolerability, PK, Bioequivalent, Bioavailability, Drug-drug (food) interactions, and Phase II/III/IV clinical studies for novel and generic drugs.
In 2013, MicroConstants China established partnership with ERT to provide in-country support for ERT’s cardiac safety and eCOA services in Greater China, including TQT/intensive ECG collection study design according to ICH E14 guideline, helpdesk, on-site training, and training at start initiation meeting, etc. to ensure proper execution of study protocol.
As a local CRO with global quality standards, MicroConstants China has served MNC, medium pharmaceutical companies and small biotech alike and contributed the approval of many imported/domestic new drugs and generics with services covering SAD/MAD/FE/PK/BE/TQT studies. Our Vision: Bridging the gap between China and global new drug development Our Mission: Facilitate new drug development through global quality system and novel clinical trial technology.