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. Our integrated team of professionals are dedicated to maximizing the potential for commercial success of your drug product. We regularly work with clients to repurpose, reposition and reformulate drugs including:
PDG’s wide range of experience across formulations, disease states, patient populations and regulatory pathways has placed us at the forefront of providing strategic drug development services for niche, repurposed and differentiated drug products.
PDG® – Strategic Drug Development Consultants
PDG is a global pharmaceutical and FDA regulatory affairs consulting firm. Unique in our ability to comprehensively and ideally integrate dosage forms, disease states, patient populations and FDA regulatory pathways, PDG’s aim is getting drug products to market smarter and faster. In doing so, we combine clinical and commercial insights, while providing assistance at all stages of drug product development from identification and choice of viable candidates through ensuring the existence of cost-effective commercialization strategies. In short, PDG designs and implements strategic drug development plans with a focus on rapid and efficient launch-readiness.
Formulation Driven with Experience Across Dosage Forms
PDG has decades of experience serving a large number of pharma clients through hundreds of pharmaceutical product development projects. Our strength is formulation driven and includes traditional oral dosage forms (both immediate and extended release), as well as work in more complex forms such as inhalers, parenterals and transdermal systems. It has been PDG’s experience that complex dosage forms represent excellent opportunities for sponsors to differentiate as well as extend the life of marketed drug products.
Proficiency Across Disease States and Diverse Patient Populations
Of critical value is our wide range of experience across disease states including therapies directed at cardiovascular, neurology, endocrine, gastrointestinal, pulmonary, analgesic, oncology, and anti-infective indications. Compounding the value of these competencies is our work with such diverse patient populations as pre-natal, pediatric, elderly, at-risk and healthy volunteers.
PDG Serves as Your Regulatory Voice at FDA
Whether you require a 505(b)(1) or 505(b)(2) NDA or you are considering your first ANDA, PDG employs experienced pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency followed by submissions that withstand FDA review and scrutiny. Follow the links below to explore more details of each service:
- Pharmaceutical Development Program: Implementation and Oversight
- Pre-IND Meetings
- Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
- Clinical Trial Design
- Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
- 505(b)(2) NDAs
- Generic Drugs: 505(j) ANDAs and Potential Diversification
- Nonprescription Drugs (OTC)
Your Turnkey Source
Solid pharmaceutical product development strategy translates into the creation of sound and detailed project plans that are designed to adjust and adapt to continuously changing circumstances. Such planning is essential to minimize overall product development time and research expenditures, as well as movement of a compound through the various phases of preclinical and clinical testing.
PDG offers one-stop-shopping for strategic drug development services including toxicology, pharmacokinetics, pharmacodynamics, clinical, statistical, epidemiology, CMC, labeling, safety surveillance and pharmacovigilance consulting. Additionally, PDG routinely sources and interacts with facilities worldwide that include clinical and animal testing sites, CROs, CMOs and API suppliers. PDG possesses the resources and experience to address large-scale development projects, long-term regulatory strategies and complex non-clinical and clinical issues. Combining clinical and commercial insights, we provide assistance at all stages of drug product development. Our integrated team of professionals have years of industry experience addressing FDA submission, approval and post-marketing assignments. Our goal is to help you maximize the market lifetime and total return on investment of your drug product. Let’s talk.