Pharmaceutical Development Group
Pharmaceutical Consultant and FDA Regulatory Strategist
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PDG provides pharmaceutical consulting as a regulatory strategist to firms located around the world, and has since 1999.
We offer one-stop-shopping to include US FDA NDA compilation and submission, design and execution of toxicology and clinical programs (phases I-IV), sourcing and oversight of third party vendors including raw material suppliers, contract laboratories, CROs, CMOs and pre-approval inspections of all such facilities.
PDG is your regulatory voice at FDA
Having facilitated hundreds of FDA pre-submission meetings and regulatory submissions for our clients, we know how to determine and navigate the best regulatory pathway for your drug development project.
From submitting a Citizen Petition to change a monograph or submitting a 505(b)(2) to repurpose a discontinued DESI drug, through priority review and accelerated approval of a new chemical entity, PDG has the expertise to see your project through.
We seek to know the answers before asking FDA the questions
While this is never entirely possible, the model characterizes the extent to which we prepare our submissions, and our clients for FDA meetings.
Our approach to determining and illustrating risks and benefits integrates products, patient populations, and disease states with toxicology, pharmacokinetics, pharmacodynamics, clinical, statistical, epidemiology, CMC, labeling and pharmacovigilance concerns.
Our clients rely upon us to facilitate innovation, prolong product lifecycles, evade generic competition, supplement dwindling pipelines and differentiate or repurpose existing drug products.
As a regulatory strategist and pharmaceutical consultant, PDG understands that improvements in safety, efficacy, bioavailability, patient compliance and convenience are viewed favorably by the FDA, as well as the marketplace.
We know through first-hand drug development experience how to help you develop novel formulations. We can also help you devise orphan, combination, or reformulation-based product development and other repositioning strategies that have the potential of yielding high returns on investment.
Typical of our services, but not entirely inclusive are the following:
- Pre-IND / End of Phase II / Pre-NDA requests, briefing packages and facilitation
- IND / Special protocol assessment (SPA)
- Design of first-in-human through Phase IV studies
- NDA compilation and submission
- Mock FDA audits
- Postmarketing safety surveillance - signal detection
- Periodic reporting (PADERs/PSURs)
- Literature reviews
- Labeling currency
- Pharmaceutical consultants for complex issues and emergencies
The optimal time to engage a consultant such as PDG is in advance of meeting with FDA. However, PDG will engage at whatever point we are called upon, including regulatory emergencies such as those caused by unplanned audits or unanticipated inspection results.
We are ready to deploy for our clients 24/7 in all time-zones, including travel to your facility when needed.
Pharmaceutical Development Group
13902 Dale Mabry Hwy, Suite 230
Tampa, Florida 33618
United States of America
+1 813 963 3062
+1 813 963 0972
505(b)(2) NDA, a timely, cost-effective route to market
Proposed labeling changes for drugs and biologics
Pre-NDA meetings and NDA submissions
Strategic drug development expertise
Global pharmaceutical and FDA regulatory affairs consultant
Available White Papers
Pharmaceutical Consulting and Generic Drug Professionals On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products'.
Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.
Medical Device Consultant on 510(k) Submissions As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.
Drug Labeling Specialist on New Pregnancy Labeling Rules On June 30, 2015, the new pregnancy labeling rules for prescription drug labeling took effect, marking the demise of pregnancy categories (A, B, C, D, X), in use since 1979.
Innovator or Generic, All Roads Lead to the 505(b)(2) Faced with decreasing R&D output, billions of dollars in patent expirations and increasing generic competition, innovators are forced to re-evaluate traditional business models.