Laboratorio Pablo Cassara

Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm headquartered in Tampa, Florida. BRG specializes in expedited commercialization pathways for pharmaceutical, biologic, and medical device companies navigating FDA and global regulatory requirements. The firm maintains a global network of expert consultants across 60+ countries with specialized expertise in toxicology, pharmacokinetics, statistics, epidemiology, and pharmacovigilance. BRG's core services span biologics (BLA, tissue registrations, vaccines, gene therapy), medical devices (510(k), PMA, PMN applications, implants, surgical devices), pharmaceutical drugs (NDA, ANDA, IND, OTC), quality assurance (ISO clean room operations, audits, SOP implementation, FDA adverse event reporting), and specialty services including emergency use authorizations, expert witness testimony, and literature reviews. The firm emphasizes FDA compliance leadership, clinical research design, and quality management as keys to regulatory success, offering cost- and time-effective tailored product development plans.