Our bioanalytical laboratory is highly equipped with state-of-the-art instruments, dedicated team and stringent Standard Operating Procedures (SOPs) to ensure accuracy and reliability in bioequivalence and bioavailability (BABE) studies.
SOPs in Bioanalytical Laboratory
Standard Operating Procedures (SOPs) in our bioanalytical laboratory ensure consistent, high-quality results and compliance with various regulatory standards such as CDSCO, US-FDA, MHRA, Canada, ANVISA, ROW etc. Our comprehensive SOPs cover all aspects of operations, including sample handling, equipment maintenance, and data management, providing clear guidance to our team and promoting reliability and efficiency in every analytical process.
Bioanalytical team
Our bioanalytical team comprises highly skilled scientists and technicians with extensive expertise in method development, Method Validation and Study sample analysis. Committed to delivering accurate and reliable results, we utilize state-of-the-art technology and adhere to strict regulatory standards, ensuring exceptional service and support for our clients in drug development and clinical research. Our team is adept at preparing for and navigating audits from multiple regulatory agencies, maintaining high-quality bioanalytical practices.
Trained Bioanalytical staff
Our bioanalytical staff is expertly trained in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) to ensure compliance with industry standards. They receive comprehensive training on instrument operation from manufacturers, guaranteeing precision and reliability. We adhere to ALCOA+ principles for data integrity and follow GAMP-5 guidelines for software validation. Additionally, our team is proficient in using validated Excel spreadsheets for data management and is well-versed in fire safety protocols, fostering a secure laboratory environment.
Bioanalytical Facility
- Our bioanalytical laboratory offers advanced LC-MS/MS systems for precise quantification and analysis of complex biological samples, ensuring accurate data for BA/BE studies.
- The processing area is equipped with variety of instruments to carryout different extraction procedures, including protein preparation, liquid-liquid extraction (LLE), and solid-phase extraction (SPE), ensuring precise sample preparation for bioanalysis.
- Solid phase extractor with 144 manifolds to comply with recent regulatory requirements
- Access-controlled freezer room, equipped with -20 °C and -70 °C freezers, includes an electronic monitoring system for continuous temperature tracking, ensuring secure and compliant sample storage conditions.
- All GxP computerized systems in our laboratory undergo comprehensive Computer System Validation (CSV) to meet stringent regulatory requirements, ensuring data integrity, compliance, and reliable performance in bioanalytical processes.
- All instruments in our bioanalytical laboratory are calibrated as per the Master Calibration Schedule to ensure accuracy and reliability. This commitment to precision supports our rigorous testing processes and compliance with industry standards.
Capability of handling-
- Chiral molecules
- Metabolites impact study
- Geometric isomer
- Positional isomer
- Endogenous isomer
- Molecules with stability challenges
- Molecules requiring derivatization
Safety in Bioanalytical laboratory
Safety is our top priority in the bioanalytical laboratory. We implement rigorous protocols and best practices to ensure a secure working environment. Our team is trained in handling hazardous materials and follows strict safety guidelines, including proper personal protective equipment (PPE) use, waste disposal, and emergency response procedures for optimal safety.
