Analytical Method Development & Analytical Method Validation as per ICH/ANVISA guideline or as per Customer requirement
Analytical Testing of Routine Samples & Stability Study Samples
Chemical Analysis (UV, Autotitrator, pH, Melting Point, Water content, LOD etc.)
HPLC Analysis (Related Substances, Assay, Chiral Impurity, %Purity etc.)
GC and GC-HS Analysis (OVI, Residual Solvents, %Purity etc.)
Forced Degradation Studies (as per ICH/ Anvisa/Brazil/EDQM and As per customer requirement)
Analytical Support related to DMF and CEP filing
All regulatory Queries related work and support (EDQM, ANVISA, CFDA, USFDA, MHRA etc.)
a) Carry over studies of degradation Impurities, process related impurities and organic volatile impurities
b) Impurity Profiling and Genotoxic Impurities evaluation of KSM (Key Starting Material) to Drug Substance.
Analytical Method Development & Analytical Method Validation as per ICH/ANVISA guideline or as per Customer requirement
Analytical Testing of Routine Samples & Stability Study Samples
Chemical Analysis (UV, Autotitrator, pH, Melting Point, Water content, LOD etc.) HPLC Analysis (Related Substances, Assay, Chiral Impurity, %Purity etc.)
GC and GC-HS Analysis (OVI, Residual Solvents, %Purity etc.)
Forced Degradation Studies (as per ICH/ Anvisa/Brazil/EDQM and As per customer requirement)
All regulatory Queries related work and support (EDQM, ANVISA, CFDA, USFDA, MHRA etc.) a) Carry over studies of degradation Impurities, process related impurities and organic volatile impurities b) Impurity Profiling and Genotoxic Impurities evaluation of KSM (Key Starting Material) to Drug Substance.
Certificate Course is benefited to get Job in Quality Control (QC) department and Analytical Development Lab (ADL) in Pharmaceutical Industries & Chemical industries.
Certificate Course is benefited to get get Job in Quality Control (QC) department and Analytical Development Lab (ADL) in Pharmaceutical Industries & Chemical industries.
