Effective project handling is crucial for success in clinical and analytical fields in today's fast-paced and highly regulated environment. Our approach leverages a dedicated team comprising Business Development professionals, Project Managers, Project Coordinators, and specialized Sample Management and Expert Teams. This collaboration ensures that every aspect of the project is meticulously managed, from strategic planning to execution.
Additionally, our adherence to comprehensive Standard Operating Procedures (SOPs) guarantees compliance with stringent regulatory guidelines, including those set by the US FDA, UK MHRA, WHO, ANVISA, and other global authorities. Together, these elements create a robust framework for delivering flawless project outcomes.
Clinical Facilities
- 2 CPU with 60 Beds
- Electronic volunteer database
- ICU equipped with patient monitor, defibrillator, suction machine, all emergency medicines
- Client requirement timeline
- Capability to perform- patch, injectable, suspension, hormonal studies in female volunteers, multidose steady-state, etc.
BA/BE Facilities
- LC-MS/MS
- Processing area equipped to carry out various extraction procedures such as protein preparation, LLE, SPE
- Solid phase extractor with 144 manifolds to comply with recent regulatory requirements
- Access control deep freezer room equipped with -20 °C & -70 °C deep freezer.
- CSV Performed for all the GXP computerized systems in the laboratory
Capability of handling-
- Chiral molecules
- Metabolites impact study
- Geometric isomer
- Positional isomer
- Endogenous isomer
- Molecules with stability challenges
- Molecules requiring derivatization
