Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

pharmaceutical consultants

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.

Available White Papers

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Drug Labeling Specialist on New Pregnancy Labeling Rules 21 July 2017 On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the demise of pregnancy categories (A, B, C, D, X), which have been in use since 1979.

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Experienced Accessible Pharma Professionals and Global Regulatory Services 18 July 2017 PDG has experienced and accessible full-time professional staff and expert consultants including a multidisciplinary team of pharmacologists, toxicologists, clinicians, epidemiologists, statisticians, analytical scientists, regulatory professionals and other product development specialists.

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Pharmaceutical Consulting and Generic Drug Professionals 16 May 2016 On November 13, 2013, FDA proposed a new rule known as the 'Supplemental Applications Proposing Labelling Changes for Approved Drugs and Biological Products'.

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Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design 15 January 2016 Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design.

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Medical Device Consultant on 510(k) Submissions 08 October 2015 As a medical device consultant, PDG® takes great interest in the ever-changing landscape of the premarket notification (510(k) review and clearance process.