We are delighted to share that our facility has successfully completed its 2 nd USFDA Surveillance GMP inspection, further demonstrating our commitment to Quality and Regulatory Compliance.
Method Development and Validation for Nitrosamine Impurities, NDSRI Impurities as per ICH, USP/USFDA, ANVISA, MCC and TGA Requirements.
Method Development and Validation for Elemental Impurities Extractable and Leachable Studies, Nasogastric Feeding Tube Studies, Method Development and Validation for Regular Chemical Testing by HPLC and GC
Method Development and Validation for Drug analysis in biological fluids as per Global regulatory Standards Special Bio- Analytical studies by using GCMS and ICPMS technique
BET (Bacterial Endotoxin Test)
MLT (Microbial Limit Test) Sterility, AET/PET, Bioburden & Water testing