Biotech Research Group

Regulatory and product development consulting includes planning and support for clinical research, FDA submissions, and compliance. The firm works with biologics, drugs, medical devices, and healthcare information technology, with services covering applications such as BLA, PMA, 510(k), NDA, and IND. It also provides quality assurance support, including audits, SOP implementation and training, environmental monitoring, and corrective actions. Additional specialties include pharmacovigilance, toxicology, pharmacokinetics, statistics, epidemiology, and emergency use authorization consulting for medical products. Biotech Research Group serves clients in more than 60 countries and offers scientific and regulatory affairs expertise across diverse therapeutic areas. Its Tampa-based consulting practice supports product development and clinical research plans tailored to client budgets and timelines.