Christina has over 20 years of management, biologics, quality assurance and research experience in the medical field.
Strategic Drug Development Services
PDG navigates the complexities of the US pharmaceutical industry for clients through our strategic drug development services that include analysis of commercial potential during early stages of clinical development in parallel with regulatory planning.
Drug Post-Launch Activities
Post-launch activities for a new drug require companies to rigorously track, report, and evaluate worldwide adverse event information. Such drug post-launch activities are critically important to ensure current benefit/risk profiles and the dissemination of labeling that fully describes the safe use of a drug product.
Quality Assurance & Compliance
For over 15 years, PDG has helped pharmaceutical firms achieve and maintain compliance with global Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and pharmacovigilance (PV) standards.
Specialty Services
Imagine the value of continuous access to the specialty pharmaceutical consulting services and resources necessary to complete tasks that are out of the ordinary, unexpected, or for which you just don’t have time.
An FDA Regulatory Consultant
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.
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.
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Regulatory Expert
Dallas L. Thomas, RAC, MHA, MPA, SSYB
Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product…
Regulatory Expert
Donald Klein, PhD
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
Sr Director of Product & Process Development
Bill Spanogle, PhD, MS
Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development
Director of Regulatory Affairs
Nadine Bewry, PhD, MS, MPH
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.
Regulatory Expert & Expert Witness
Joshua Sharlin, PhD
Dr. Sharlin is a former FDA drug reviewer, an FDA regulatory expert witness (10 years)…
VP of Global Business Development
Michael Miller, MBA
For more than 20 years, Michael has developed innovative solutions for customers across the globe.