PDG is an FDA regulatory affairs and global pharmaceutical consultant with extensive experience in the strategic development of 505(b)(2) drug products. From identification and choice of viable candidates through ensuring the existence of cost-effective commercialization strategies, PDG is unique in its ability to comprehensively and ideally integrate dosage forms, disease states, populations and FDA regulatory pathways.
- Orphan Drugs
- Combination products
- Tentative and Final Monograph products
- DESI drug products
- Orphan drug products
- Oral delivery systems (capsules, tablets, rapid dissolve, controlled release)
- IV & injectable delivery systems
- Topical & transdermal delivery systems
- Pediatric formulations
- Products for inhalation
- Dietary supplements & cosmetics
- Cough / cold
- Endocrine / hormone replacement
Since its founding in 1999, PDG has served as an FDA pharmaceutical consultant to firms located in North America, South America, Europe and Asia. PDG offers one stop shopping to include toxicology, pharmacokinetics, pharmacodynamics, clinical, statistical, epidemiology, CMC, labeling, safety surveillance and pharmacovigilance consulting. PDG possesses the resources and experience to address large-scale development projects, long-term regulatory strategies and complex non-clinical and clinical issues. The company’s in-depth knowledge of the science, regulatory affairs, commercial concerns, review processes and interactions with FDA spans a variety of dosage forms and therapeutic areas.
PDG leadership, employees and contractors include former pharmaceutical industry executives, experienced pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals and other product development specialists. After years of growth, PDG prides itself on remaining nimble in response to planned, as well as unexpected regulatory needs. PDG competence in dealing with regulatory issues is reflected in a consistent track record of successful results. Because of this success, not surprisingly, many of our very first clients continue to engage our services. Indeed, one of PDG’s most treasured marks of success is that its growth is propelled by a high proportion of repeat business.