-
Development, qualification, validation, and transfer of HPLC/GC assay and impurities methods
-
Forced degradation studies including ID of the degradation products
-
Providing analytical and stability data for regulatory submissions
(Module 3)
-
Development and validation of methods for PGIs at the ppm levels per ICH M7
-
Chiral HPLC method development and validation
-
Impurities identification, structure elucidation


-
Formulation development support: Tox formulations, stability, excipient compatibility, solubility
-
Development of dissolution methods including NDA level discriminating methods
-
Dissolution testing in biorelevant and QC media in support of DOE and regulatory submissions
-
GMP release testing and ICH stability studies for DS and DP Phase 1-2 clinical programs
-
Reference standards characterization and management

-
Development, qualification, validation, and transfer of HPLC/GC assay and impurities methods
-
Forced degradation studies including ID of the degradation products
-
Providing analytical and stability data for regulatory submissions (Module 3)
-
Development and validation of methods for PGIs at the ppm levels per ICH M7
-
Chiral HPLC method development and validation
-
Impurities identification, structure elucidation
-
Formulation development support: Tox formulations, stability, excipient compatibility, solubility
-
Development of dissolution methods including NDA level discriminating methods
-
Dissolution testing in biorelevant and QC media in support of DOE and regulatory submissions
-
GMP release testing and ICH stability studies for DS and DP Phase 1-2 clinical programs
-
Reference standards characterization and management
-
Reference standards characterization and management