Pharmaceutical Development Group Pharmaceutical Regulatory Consultant and FDA Regulatory Strategist
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.
Products and Services
Many PDG clients have found the 505(b)(2) new drug application (NDA) development pathway to be a more timely and cost-effective route-to-market.
Generic Drug Development: 505(j) ANDAs and Potential Diversification
PDG and its staff have participated in more than 100 505(j) abbreviated new drug applications (ANDA) submissions.
International and US companies rely on the expertise and professional resources of PDG to provide dependable, accurate, and compliant drug safety programmes, pharmacovigilance services, and ongoing assessments of labelling accuracy and completeness.
PDG's team of industry professionals has extensive experience in planning pre-investigational new drug (IND) Meetings on its clients' behalf (as well as other Type B Meetings). This includes strategy, preparation, facilitation and post-meeting follow-up.
Pre NDA Meeting and NDA Submission: 505(b)(1)/505(b)(2)
PDG has participated in multiple new drug applications (NDA), (505(b)(1), 505(b)(2)), and supplemental new drug applications (sNDA), including first-in-class drug products, new chemical entities, prescription (Rx) to over-the-counter (OTC) switches, and fixed-dose combinations.
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.
Drug Labeling Specialist on New Pregnancy Labeling Rules
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.
Experienced Accessible Pharma Professionals and Global Regulatory Services
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.
A Guide Accross the Regulatory and Scientific Terrain
Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration (FDA).
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).Read more
The US market is to gain access to previously unavailable therapeutically equivalent generic drug formulations due to a number of changes.Read more
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.Read more
Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?
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?Read more
FDA consultants take note: expedited development and review programmes have now been used by CDER for more than two decades.Read more
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.Read more
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.Read more
As a pharmaceutical consultant engaged in smoking cessation efforts and generic pharmacovigilance for several years, PDG has monitored two proposed rules closely.Read more
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.Read more
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. Read more
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.Read more
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.Read more
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.Read more
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.Read more