FBL has more the 15 years of experience in the development of analytical methods for the determination of small molecules, peptides, and metabolites in different human compartments including plasma, serum, urine, peripheral blood mononuclear cells, and tissue samples. We can develop customized methodologies for our clients as well as implementing validating assays (technical transfer) complying with timeline goals. Challenging assays are welcome by our scientists and we are available for consultation, design and writing of bioanalytical protocols. We are committed to provide quality results using GLP, Lean-Six Sigma and FDA regulations.

The validation of analytical methods is essential to obtain data necessary to support regulatory submissions of the pharmaceutical product. We follow the latest validation guidelines established by the industry and federal agencies, providing quality data to our customers. FBL uses the following validation parameters for research or for submission to a regulatory agency: (i) accuracy, (ii) limit of detection, (iii) limit of quantitation,(iv) linearity, (v) precision, (vi) range, (vii) robustness, (viii) ruggedness, and (ix) specificity.

The quality control team of Fundacion de Investigacion de Puerto Rico is in charge to independently monitor the performance of FBL following GLP and FDA guidelines and regulations. This team is involved in the internal auditing of studies and FBL facilities. They are in charge of administering CAPA and document control systems; reviewing equipment qualification, calibration and maintenance. The studies performed at FBL are of the highest standards complying with regulatory requirements. A sample chain of custody is in place to determine the location at all times. The Director of FBL, Dr. Jose F. Rodriguez-Orengo, was past Executive Director of the Puerto Rico Institute of Forensics Sciences and implemented a system where the Institute obtained accreditation by 5 different US regulatory agencies in 2 years.