Bioanalytical Services
- Capabilities
- Infrastructure
- Services
- Why us?
Validated Methods
Under Development & Validation
Bioanalytical Services
 
bullet Capabilities:

bullet Ability to develop and validate methods well in advance based on patent expiry and business sense
bullet Ability to accommodate urgent bioequivalence projects
 
bullet Infrastructure:
 
bullet Spacious wet labs having:

bullet Well built working benches having proper exhaust systems on each bench
bullet Fume hoods to carry out evaporations
bullet Air handling units
bullet Separate lab to handle light sensitive molecules
 
bullet State-of-the-art Instrumentation:

bullet More than 30 LC-MS/MS systems
bullet API SCIEX, Waters and Thermo
bullet HPLC systems with UV and Fluorescence detection
 
bullet Chromatographic modes available:

bullet Normal and reversed phase
bullet Ion exchange
bullet Chiral Assay
 
bullet Scientific Data Management System:

bullet Review the chromatographic data online using Nugenesis® and catalogue data
bullet Project-wise enabling easy retrieval
 
bullet Sample storage:

bullet All study samples are preserved in secure freezers, controlled and monitored round the clock, and supported by a standby generator
bullet Low temperature storage (2-8° C, -20° C and -80° C)
bullet Capacity to store more than 2.5 million samples


 

bullet Services:

bullet Method development/Method validation
bullet Method transfer for drugs in biological matrix
bullet LC-MS/MS and HPLC analysis of drug and metabolites in biological matrix from clinical trials
bullet Sample storage at -20° C and -80° C
 
bullet Why us?

bullet Rapid turn-around-time
bullet Capability to handle liquid-liquid extractions, solid phase extractions and derivatization procedures
bullet Chiral separations of optical isomers
bullet Estimation of conjugated and non-conjugated drug levels
bullet Customized assay method
bullet Expertise in different matrix handling such as plasma, serum, urine and whole blood
bullet Expertise in handling regulatory audits

 

Lambda Therapeutic Research Ltd.
A CRO for Clinical Research, Clinical Trials, Medical Writing, Bioanalytical, Bioequivalence and Pharmacovigilance services.
India (Ahmedabad - Mumbai), Poland (Warsaw), USA