Technical Articles
16 May 2024
Characterization and Evaluation of Amorphous Solid Dispersion-Part 2
16 May 2024
CMC: Experts in BLA filings for drugs at biophysical/chemical section using LC-MS under regulatory guideline for drug approval with several large pharma including Celgene/BMS and Acceleron/Merck.
Preclinical: Experts in serum stability and in-vivo CQA analysis to assure drug candidate selection in pre-clinical stage.
Clinical: Extensive experience in gap analysis of CMC issues related to clinical development.