Pharmaceutical Development Group Pharmaceutical Regulatory Consultant and FDA Regulatory Strategist

pharmaceutical consultants

Pharmaceutical Development Group (PDG) provides pharmaceutical regulatory consulting to firms located around the world.

The company offers a one-stop-shop for US Food and Drug Administration (FDA) new drug application (NDA) compilation and submission, design and execution of toxicology and clinical programmes (Phases I-IV), sourcing and oversight of third party vendors including raw material suppliers, contract laboratories, contract research organisations (CRO), contract manufacturing organisations (CMO), and pre-approval inspections of all facilities.

FDA regulatory consultants for pharmaceutical development

Having facilitated hundreds of FDA pre-submission meetings and regulatory submissions for its clients, PDG knows how to determine and navigate the best regulatory pathway for your drug development project.

From submitting a Citizen Petition to changing a monograph or submitting a 505(b)(2) to repurpose a discontinued drug efficacy study implementation (DESI) drug, through priority review and accelerated approval of a new chemical entity, PDG has the expertise to see your project through.

PDG seeks to know the answers before asking FDA the questions

While this is never entirely possible, the model characterises the extent PDG prepares its submissions, and clients for FDA meetings.

The company’s approach to determining and illustrating risks and benefits integrates products, patient populations, and disease states with toxicology, pharmacokinetics, pharmacodynamics, clinical, statistical, epidemiology, CMC, labelling, and pharmacovigilance concerns.

PDG facilitates innovation, prolongs product lifecycles, evades generic competition, supplements dwindling pipelines, and differentiates or repurposes existing drug products.

As a regulatory strategist and pharmaceutical consultant, PDG understands that improvements in safety, efficacy, bioavailability, patient compliance, and convenience are viewed favourably by the FDA, as well as the marketplace.

The company knows through first-hand drug development experience how to help you develop novel formulations. It 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 (ROI).

Typical of our services, but not entirely inclusive are the following:

  • Pre-Investigational new drug (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
  • Labelling 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.

PSG is ready to deploy for its clients 24/7 in all time-zones, including travelling to your facility when needed.

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Press Release

Gaining an Understanding of Pharmacokinetic Protocols

Engaged in pharmaceutical consulting, the scientists and regulatory professionals at PDG® are tasked with design of pharmacokinetic (PK) protocols for a wide variety of applications.

White Papers

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.

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Press Release

6 September 2017

The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review process and finalise pending monographs as quickly as possible. To that end, they are seeking passage by Congress of The OTC Monograph User Fee Programme (OMUFA).

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30 August 2017

Pharmaceutical Development Group has announced it will be attending this year's AAPS Annual Meeting and Exposition in San Diego.

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13 July 2017

The US market is to gain access to previously unavailable therapeutically equivalent generic drug formulations due to a number of changes.

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22 June 2017

Pharmaceutical consulting and generic drug professionals: What is your hedge against the increasingly crowded traditional drug markets?

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24 May 2017

Pharmaceutical consulting and generic drug professionals: What is your hedge against the financial risk associated with increasingly crowded traditional drug markets?

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8 February 2017

Engaged in pharmaceutical consulting, the scientists and regulatory professionals at PDG® are tasked with design of pharmacokinetic (PK) protocols for a wide variety of applications.

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19 January 2017

Pharmaceutical consulting and generic drug professionals: What are you doing to circumvent the increasingly crowded traditional drug markets?

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28 September 2016

Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling and includes reference to the regulatory basis for each.

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26 September 2016

Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a Quality Management System (QMS) in place and experience with drug submissions, so this should be easy?

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31 August 2016

FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for further drug and device development.

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14 July 2016

Deciding whether third party review is a favorable cost/benefit proposition for a given 510(k) development programme is not always clear.

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22 June 2016

Drug product labelling is the primary communication tool for any drug product.

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16 June 2016

FDA consultants take note: expedited development and review programmes have now been used by CDER for more than two decades.

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2 June 2016

Pharmaceutical consulting and generic drug professionals: On February 18, 2014, the final guidance document was released regarding FDA's Pre-Submission programme, Requests for Feedback on Medical Device Submissions: The Pre-Submission Programme and Meetings with Food and Drug Administration Staff.

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18 January 2016

The value of adaptive clinical trial consulting and pharmaceutical consulting is highly correlated with up-to-date knowledge of the state of adaptive trial design.

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12 October 2015

Medical device consultants tend to take great interest in the dynamic pre-market notification (510(k) regulatory landscape.

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3 September 2015

As a pharmaceutical consultant engaged in smoking cessation efforts and generic pharmacovigilance for several years, PDG has monitored two proposed rules closely.

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6 May 2015

India's pharmaceutical industry has grown at record levels in recent years but now faces unprecedented challenges as the number of blockbuster drugs scheduled to go off patent begins to decline.

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5 May 2015

As a pharmaceutical consultant, I note that many have speculated the era of the blockbuster drug has ended. 2014 marked the sixth year of a patent cliff in which a majority of US blockbusters fell to generic competition. [1]

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13 April 2015

Rx to over-the-counter (OTC) switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail drug space represent huge market potential.

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6 April 2015

Many have speculated that the era of the blockbuster drug has ended. 2014 marked the sixth year of a patent cliff in which a majority of US blockbusters fell to generic competition.

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30 March 2015

The US Food and Drug Administration (FDA) recently announced that fixed-combination drugs (FCD) comprised of at least one NCE will be eligible for five years of exclusivity.

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24 March 2015

PDG, a pharmaceutical consultant company, understands that drug manufacturers rely on reformulation for prolonged product lifecycles to protect against generic competition, supplement limited pipelines and repurpose existing drug products.

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4 December 2014

US Food and Drug Administration (FDA) has delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the CBE process.

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25 November 2014

Pharmaceutical Development Group (PDG™), a pharmaceutical consultant, has published a chronology of events relating to FDA's proposed rule that would allow generics to use the CBE process to update their labeling with new safety information.

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