Pharmaceutical Development Group (PDG) assists FDA regulated firms in the navigation of the U.S. submission, approval and post-marketing procedures across a variety of dosage forms and therapeutic areas. Our expertise spans prescription and nonprescription (OTC) drugs, both NDA and monograph, as well as devices.
While PDG possesses the resources and experience to address large scale development projects, long-term regulatory strategies and complex non-clinical and clinical issues, we remain as nimble and responsive as the day of our founding. We can quickly and efficiently address unexpected emergencies. PDG maintains a posture of readiness to react and respond to your needs and regulatory urgencies 24 hours a day, 7 days a week. We recognize that you may receive an FDA Form 483 or Warning Letter, may be faced with the possibility of a recall, or have encountered some other sudden and urgent situation. Regardless of the emergency, as your FDA regulatory consultant, PDG is always ready to respond without delay.
We focus our experiences and energies to serve as your long-term regulatory partner throughout product lifecycles. PDG will develop strategic plans and lifecycle management options designed to maximize the safety, efficacy, and commercial value of your products.
PDG’s clients span the globe and count on us for rapid availability and accessibility. Our team is always prepared to travel to your facilities, FDA, CROs, CMOs, or wherever the need arises. Join other successful companies who have chosen PDG to serve as a long-term partner in the maximization of the value of their drug products.
USA TEAM MEMBERS
Christina Sanchez Miller, MPH
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 Patterson, PhD
Chief Scientific Officer
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 Scheer, MPH, RAC
VP of Epidemiology and Pharmacovigilance
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. Along with finishing his Ph.D. dissertation in epidemiology, Darren is contributing 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 Alberdi, MPH, RAC
VP of Regulatory Affairs
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.
Michael Miller, MBA
VP of Global Business Development
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.