Not all scientific research organizations are equal. Biotech Research Group (BRG) is open 24 hours a day, 7 days a week, all year long. BRG experts work diligently to meet our global client’s needs. BRG understands the importance of having your questions addressed and collaborating on your time. BRG consists of doctors, researchers, toxicologists, epidemiologists, pathologists, and public health professionals in over 60 countries, allowing us to serve the global community.
Christina has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. She has assisted foreign health departments in writing legislation and working with clients in over 60 countries with licensures and permitting. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
Catherine has over 25 years of experience in directing scientific research. She has extensive experience in scientific research and writing including ongoing regulatory-based and trial-related client projects. Her recent work has focused on human drugs/devices, clinical trials and pharmacovigilance and safety. As an assistant professor, Catherine’s research and teaching was focused on immune responses, viruses and cannabinoids. Her Ph.D. is in Molecular Biology from Princeton University. Catherine’s peer-reviewed publications and patent span her years of laboratory research, and she continues to blog, review manuscripts submitted to journals and judge medical/life science abstracts, posters and awards. She has publicly published and presented her own research and scientific findings, including internationally, in over 100 venues.
Darren has more than 20 years of experience with FDA regulated products, including drugs, biologicals, devices and combination products. He has directed and developed various pharmacovigilance and epidemiological assessments. These include over 200 regulatory and development projects requiring FAERS analyses, health claims database assessments, and adverse event/safety summaries. Many of these focused on product labeling adequacy. In addition to clinical protocol development and scientific writing, he has conducted hundreds of literature reviews and product assessments. His Ph.D. in Epidemiology allows Darren to be a key participant in the program development and teaching of pharmacovigilance, regulatory affairs, and product labeling at the College of Public Health, University of South Florida in Tampa.
Mikel has vast knowledge and experience with FDA regulations and compliance relating to drugs, biologicals, devices and combination products. He has 15 years of regulatory affairs experience including preparation of FDA submissions (NDA, 505(b)(2) NDA, ANDA, IND), Pre-IND, Pre-NDA, End-of-Phase submissions and facilitation of meetings with FDA. His experience also spans eCTD, Amendments, Supplements, Annual Reports, Drug Master Files, Citizen Petitions, clinical and nonclinical study design and interpretation, finished Product/ API site audits and CRO qualifications, cGMP audits (foreign and domestic). He also manages our electronic submission gateway (ESG), eCTD compilation, review, validation and submission to FDA, as well as electronic Drug Establishment Registrations and Product Listings.
For more than 20 years, Michael has developed innovative solutions for customers across the globe. He has negotiated agreements with governmental authorities in the Middle East, Asia, Africa, Europe and the Caribbean to insure his clients are able to transact business in the US with seamless integration. In his role at Biotech Research Group, Michael provides synergistic approaches for international and domestic customers to create efficient solutions for regulatory, legal, and developmental needs.