Bioanalysis Services
Biotrial’s Bioanalytical Services (BBS) offer a wide range of solutions to the pharmaceutical and biotechnology industries: method development, validation, methodology transfer and analysis of Preclinical and clinical samples in biological matrices. We are committed to building long-term relationships with our clients!
More about BBS
One of our distinguishing features is our ability to develop some of the most challenging assays. A highly trained team of R&D scientists use the latest techniques and routinely resort to custom synthesis of stable-labeled reference compounds and metabolites to ensure that the methods are sensitive, robust and highly selective.
Our specialists, working closely with R&D, rigorously and meticulously test each method in accordance with the most recent regulatory agencies’ guidance.
Expert Knowledge & Regulated Bioanalysis
Bioanalysis Services Provided: Method development/adaptation, Method Qualification, Method Validation, Tech Transfers, Bioequivalence Studies, Bioavailability Studies, First to File, ADME/TK/PK/PD/DDI Analysis, Clinical / Preclinical Sample Bioanalysis, Therapeutic Drug Monitoring.
Our Standard Operating Procedures corroborate compliance with Good Laboratory Practice and are harmonized with current regulatory bioanalysis guidance by EMA and FDA agencies.
On-Site Equipment / Instrumentation
- LC/MS/MS including API 4000 and AB Sciex QTRAP®6500
- Shimadzu HPLC systems: SIL-20AC HT Autosampler /LC-20AD Pumps / CTO-20A Column Ovens
- Walk-in -20˚C freezer: 163 m3 / 5,760 ft3
- 17 -70˚C freezer units:
- A Monthly capacity of about 10,000 samples
- 24-Hour computerized temperature monitoring
Added values
Experts implicated in R&D process
Specialized in developing selective and sensitive assays and meeting objectives required at each stage of drug development.
Innovation
Routine support of innovator drug development with challenging assays, achievable owing to experience and capability.
Fast Turnaround Time
Our scientists, project managers, laboratory specialists, and instrumentation specialists are committed to delivering reliable results on-time.
Flexible
BBS supports trials with a team of experts who utilize efficient methodologies to meet demanding deadlines.
Our team
Our experienced and well-trained production team is known for delivering industry-leading turnaround times, including the sought-after “first-to-file” studies, on time and without compromising quality.
