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

President/CEO

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.

Dallas L. Thomas, RAC, MHA, MPA, SSYB

Regulatory Expert

Dallas L. Thomas, RAC, MHA, MPA has 14 years’ experience in the medical device industry in the areas of regulatory affairs, quality management systems, compliance, auditing, and clinical evaluation. Dallas works on activities associated with FDA submissions, particularly 510(k), Emergency Use Authorizations, FDA Enforcement Policies, FDA Establishment Registration, UDI, GUDID, CE Marking per EU MDR 2017/745 maintaining regulatory approvals, compliance to ISO 13485:2016, MDSAP Audits, Internal Audits, Gap Audits, Supplier Audits, FDA regulatory and quality support, and European regulations among other international market authorizations of products, and clinical evaluation reports (CERs). His qualifications include Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society, Certified Lead Auditor for ISO 13485 issued by BSI, and is a Six Sigma Yellow Belt. He also brings his education to our team with a Bachelor’s in Human Development, Masters’ of Healthcare Administration, and Masters of Public Administration. He has experience working with multi-disciplinary teams supporting product development and product sustaining. Dallas also brings exposure to national & international regulatory standards such as the new EU Medical Device Regulation (MDR), Good Manufacturing Practices (GMPs), ISO 13485, ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185 (ANVISA in Brazil), MDD 93/42/EEC, and Latin America regulations among others. Dallas also bring his multilingual skills to our team, as he is fluent in Portuguese and Spanish, and has lived abroad in Latin America in the past.

Donald Klein, PhD

Regulatory Expert

Dr. Klein is a regulatory, scientific CMC Expert with 23 years (1995 – 2017) of experience as a Senior Review Chemist of new drugs in CDER/FDA where he received upon retirement the FDA Distinguished Career Service Award (2017) from the FDA Commissioner. While at the FDA, Don significantly contributed to developing FDA policies for pharmaceutical packaging, comparability protocols, and drug master files. With respect to post-approval changes, his last 12 years were dedicated to the CDER CMC post-marketing division. In addition, Don worked with fellow FDA experts and Industry to resolve drug shortage issues from 2005 to 2017. Prior to starting a Consulting Company (7/2019) with his wife Lynda Taskett, Dr. Klein was a CMC Consultant at parexel (9/2017 – 6/2019). In his professional career he has either reviewed or drafted applications in the following therapeutic areas: Oncology, AIDs, Neurology, Psychiatric, Metabolic/Endocrine, Dermatology, Pulmonary, Analgesic, Radiopharmaceutical; and OTC. Combining his FDA and consulting career, Don has completed 41 NDAs – NDA RSs and 131 original INDs. As a Consultant he has directed Clients through 5 F2F pre-IND meetings and 4 pre-NDA meetings.

Don has been an invited speaker at AAPS, PDA, and RAPS Conferences and had presented several internal training seminars (1999 – 2017) to the FDA Staff. He received a B.S. in Chemistry from Allegheny College (1982) and a Ph.D. in Synthetic Organic Chemistry from Emory University (1988).

Bill Spanogle, PhD, MS

Sr Director of Product & Process Development

Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development, RA/QA, EU-MDR/IVDR, QbD, and CSV-GAMP-Part11. Bill has  successfully characterized and taken scores of medical devices, Biotech, Pharma, and Combo Products, Designs, Materials, & Processes from concept through commercialization via QbD, Design Controls, Risk, PMS, CER, PRRC, data trending, submissions, site inspections, turnarounds, and all intermediate functions. He is a recognized international & domestic invitational Biotech, medical device, Combo, CSV, and regulated life science leader, presenter, assessor, remediator, instructor, implementor, and author. Those who have and do work with Bill, continually nickname him “Doctor Bill” for his passion, skills, integrity, and compassion in effectively aligning and harmonizing people and organizations within the regulated life science Industry. Bill’s Regulated Life Sciences background includes, but not limited to, Management, Leadership, and Director Levels for J&J Medical Devices, Biotech, Stem Cells, IVDs; turnaround of Carefusion, and IVD Submissions Serono-Baker, respectively. These experiences span several decades, multiple continents, numerous International Regulatory Bodies. His Medical Device Design Control expertise has its roots in my nearly five years of Software Design and Development and Controls. To-date Bill has led and guided >4000 professionals, across multiple global Sites, in Design Controls, CSV, Part 11 GAMP & QbD, and 1000s of professionals as an Invitational Presenter at numerous Professional Conferences, and 1000s more via publications and ISPE Guide Series.

Nadine Bewry, PhD, MS, MPH

Director of Regulatory Affairs

Nadine is a former FDA Regulatory Scientist and Project Manager. She has over 10 years of experience with FDA regulated products, including drugs, biologicals, combination products, and food ingredients. She is a Regulatory and Medical Science Professional with clinical research and pharmaceutical experience. Additionally, Nadine’s areas of expertise also include regulatory body, key opinion leader, and stakeholder engagement; regulatory, and business planning; technical data organization and analysis; and written and verbal communication and presentation. Nadine continues to write scientific commentaries and review biomedical research manuscripts and abstracts submitted to scientific journals. Her Ph.D. and M.S. are in Medical Science from the University of South Florida College of Medicine and her Master of Public Heath (MPH) is from Johns Hopkins Bloomberg School of Public Health.

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.