Our strategic alliance with USFDA, one of the largest research Laboratories based in Mumbai, India enables us to provide varied services including:
BIOAVAILABILITY(BA) & BIOEQUIVALENCE(BE) PROJECTS Our comprehensive service package for Bio trials covers complete management issues with services and flexibility that meets all of the clients needs. The Clinical investigation department has complete knowledge of international guidelines for conducting Bio studies and the study is undertaken strictly on the basis of approved protocols with requisite authorization from the ethics committee.
We offer a comprehensive range of phase (I) services that are provided both individually or in combination. We offer services for a complete range from clinical conduction to bio analytical work till report writing. Our range includes:
| Pilot BA/BE studies. |
Pivotal BA/BE studies. |
| Bioanalysis. |
Pharmacokinetics. |
| Pharmacokinetics in special population. |
Steady state levels. |
| Development metabolism. |
Food effect in Vivo. |
| In Vitro (IVIVC) correlation. |
Statistical design and Full Biostatistics. |
BIOANALYSIS Our trained & motivated staff have the capability of performing complex & special assays. Well validated as per the prevailing international guidelines, we have with us extensive experience in detection of parent drug & metabolites in the human and animal fluids. We offer:
• Method development, validation & analysis of drugs, bio-molecules and metabolites in the body fluids of human subjects.
• State-of-the-art instrumentation backed by scientific talent that assists us in providing clients with rapid method development.
• Methods used by us comply to the international regulatory standards.