FDA Inspection for Compliance with GLP Regulations
On September 20, 2012, an investigator from the FDA visited MicroConstants’ San Diego facility for a routine inspection to assess our overall compliance with Good Laboratory Practice (GLP) regulations. The five-day inspection took place across the entire facility. Several method validations, three sample analysis projects, and a pharmacokinetic analysis report were selected to be investigated in more detail, with the inspector carrying out detailed inspections of the equipment used in each. Following the extensive evaluation, the investigator reported zero findings, observations, or recommendations.
2012 Client Surveys Reveal 100% Satisfaction
Every year, we send surveys to all our clients to measure their level of satisfaction and request feedback on ways we can improve. Our latest survey wrapped up in November and here are the results…
Below are some comments from a few of the survey respondents…
We are extremely pleased with these results and will continue to do everything we can to consistently meet our customers’ needs and exceed their expectations.
AAPS Annual Meeting & Exposition
In October, our lead Pharmacokineticist, Ahmed Kousba, M.D., Ph.D., presented three posters on toxicokinetics at the AAPS Annual Meeting. PDFs of these posters are available on our website using the links below:
North American Regional ISSX Meeting
Our Director of DMPK, David Johnson, Ph.D., presented a poster at the North American Regional ISSX Meeting in October. View a PDF of the poster on our website using the link below:
Bioanalysis (GLP and non-GLP)
MicroConstants is one of the largest bioanalytical LC/MS/MS service providers on the West Coast of the United States, housing 15 LC/MS/MS systems and occupying 34,000 square feet of office and laboratory space in San Diego, California.
Our Bioanalytical Chemistry Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LC/MS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and fluorescence detection. We have experience analyzing API and metabolites in more than 25 different biological matrices and can provide bioanalytical support throughout all the stages of drug development.