Mandava Associates provides complete bioanalytical services for support of compound development candidates through our teaming agreements with various laboratories worldwide. Performing the necessary pre-clinical studies is paramount in understanding the physical/chemical properties of the API and provides the foundation for future formulation studies.
We are able to offer method transfer, development, validation and analysis of preclinical and clinical biological samples in a GLP-compliant setting. Some of the services include:
Studies to include solid state form, pKa, LogP, solubility, excipient compatibility, container compatibility, bulk and solution stability and often pH vs. stability and pH vs. solubility studies.
Comprehensive assay development, transfer, validation and sample analysis technologies in multiple biological species.
Accurate, high-quality results in compliance with GLP standards from our expert scientists, GMP/GLP laboratories and experienced quality assurance (QA) staff.
Mandava Associates has extensive experience in providing bioanalytical methods tailored to meet the specific needs of the compound in development. We have access to the latest techniques and can advise and consult on the best analytical procedures for complex assignments and that assure only necessary data is generated minimizing costs.