Company Profile

Sourcing Inquiry Logo Pharmaceutical Development Group (PDG), Inc.

Pharmaceutical Development Group (PDG), Inc.

Regions
North America
Countries
United States
Size
n.e.
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Medical Devices
Service category
Regulatory services - CMC writing - medical writing, Consulting - strategy and development
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Key services

Services

 

Regulatory Submissions

PDG is your Regulatory Consultant

 

PDG serves the pharmaceutical, biologic and medical device industries as regulatory and product development strategists. The design and execution of successful product development efforts and regulatory approval programs are the foundation upon which PDG was built. Our experienced and highly trained staff enjoys a long and successful history of work directed to FDA regulated products.

PDG's experience includes the design, execution and oversight of all phases of product development, including strategic design of regulatory programs, clinical studies (Phases I-IV), non-clinical programs, formulation and CMC related assignments, manufacturing practices, statistical assignments, product labeling, ongoing compliance, and post marketing safety surveillance programs.

PDG's unique mix of expertise permits us to strategically address all components of the regulatory submissions relating to non-prescription and prescription drug products (both generic and innovator products), biologics, and medical devices.  Click here to learn more about how PDG can help with your product development program:

  • Drugs
  • Biologics
  • Medical Devices

 

Drug Applications

PDG is your Pharmaceutical Consultant

Introducing new drug products to the U.S. market in the current regulatory environment is a complex undertaking that can be both lengthy and and expensive. However, developing a relationship with the right FDA consultant, such as PDG, can help limit the resources necessary to achieve FDA approval of your NDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, or an ANDA (505(j)), PDG has developed proven methods of streamlining the pre-approval process to help you launch your product successfully - on schedule and on budget.

Our staff of professionals will work with you continuously to maximize the safety, efficacy and commercial value of your drug product.  PDG's business is all about growing your business, including line extension, strategic planning, additional indications, and more.

 

Investigational New Drugs (IND) 

  • Pre-IND Briefing Packages and Preparation for FDA Meetings
  • Pre-IND Meetings with FDA
  • Preparation and Submission of INDs
  • Preparation and Submission of Amendments
  • Post-submission IND Reports and IND Maintenance
  • Development of Special Protocol Assessments (SPA)
  • Drug Master Files (DMF)
  • Interactions with FDA
  • Regulatory Consulting

New Drug Applications (NDA); 505(b)(1), 505(b)(2) Applications & Abbreviated New Drug Applications (ANDAs)

  • Preparation and Submission of Complete NDA Submissions employing Original and Common Technical Document (CTD) Formats
  • 505(b)(2) NDA Development Programs and FDA Submissions
  • Preparation and Submission of ANDAs (505(j) Applications)
  • Fast Track Drug Development/Continuous Marketing Applications
  • Orphan Drug Designations
  • Preparation and Submission of Amendments
  • Preparation of Initial and Subsequent Product Labeling (Professional and Patient) 
  • Post-submission NDA Reports and Maintenance
  • Post-marketing Safety Surveillance
  • Quarterly and Annual Reports
  • Point of Contact for Domestic and International Regulatory Agencies
  • Interactions with FDA
  • Ongoing Reviews of Labeling Adequacy
  • Regulatory Consulting

Biologics
PDG is your Biologics Consultant


In today's marketplace, the development and manufacture of biologics is competitive and highly regulated. PDG's, experience in preparation and review of Biologic License Applications to CBER and CDER could mean the difference in being competitive with a successful launch or costly delays.  At PDG, we can tailor product-specific strategies to maximize both safety and profitability throughout the lifecyclye of your product.

  •     Biological License Applications (BLAs)
  •     Biosimilars
  •     Facility and Pre-Approval Inspection
  •     GLP/GMP audit preparation and response
  •     Amendments and Supplements to your BLAs
  •     Post marketing safety surveilance
  •     Quarterly and Annual Reports
  •     Regulatory Consulting

 

Medical Devices

PDG is your Medical Device Consultant 

PDG’s consultants are experienced in both medical device and combination product development, evaluation, registration and review.  PDG is positioned to help provide assistance and expertise in accessing the U.S. market including help with ISO and GMP quality system compliance, post-market vigilance, distributor qualification and clinical trials.

  • Investigational Device Exmptions (IDE)
  • Premarket Notifications (510(k))
  • Premarket Approvals (PMAs)
  • Humanitarian Device Exceptions (HDE)
  • Master Files for Devices (MAF)
  • Corrective and Preventive Actions (CAPAs)
  • Quality System Regulations (QSR) Compliance
  • Post-Marketing Safety Surveillance
  • Quarterly and Annual Reports
  • GMP Regulatory Compliance
  • Mock Audits
  • Ongoing Reviews of Labeling and "Instructions for Use" Adequacy
  • FDA 483 or Warning Letter Response
  • Regulatory Consulting

Regulatory Assistance
PDG is your Regulatory Consultant


PDG offers a full spectrum of pharmaceutical consulting services supported by uniquely diverse expertise designed to target effective regulatory strategies to suit your individual needs.

Included among PDG's specialized services are the compilation of SOPs, design, planning, and implementation of pivotal non-clinical and clinical trial protocols, designation as regulatory points of contact for international manufacturers, global pharmacovigilance and post marketing surveillance responsibilities, preparation, and response for GCP/GLP and cGMP inspections.

PDG's consulting services include, but are not limited to:

  •     Patent and trademark assistance
  •     Regulatory reviews of scientific literature
  •     Scientific and technical writing
  •     Development of non-clinical protocols
  •     Development of pharmacokinetic protocols
  •     Development of clinical protocols
  •     Clinical site audits
  •     Compilation and/or assessment of regulatory submissions, including INDs, IDEs, ANDAs, NDAs, BLAs, DMFs, MAFs, 510(k)s, PMAs, HDEs, and amendments and supplements
  •     Preparation of FDA meeting packages
  •     Preparation of Investigators Brochures
  •     Quality Assurance assistance
  •     Contract negotiations with vendors, laboratories, and contract research organizations (clinical and non-clinical)
  •     Preparation and maintenance of Citizen Petition submissions
  •     Compilation of SOPs across functional areas
  •     Preparation of NIH and other grants including CRADA and SBIR
  •     PDUFA interactions/waivers
  •     Risk Evaluation and Mitigation Strategies (REMS)
  •     Review of promotional and marketing materials
  •     Preparation for GCP/GLP and cGMP inspections and follow-up activities
  •     Assistance with FDA audits, post-audit activities, field corrections, and recall activities
  •     Preparation of Pre-approval and Post-approval labeling
  •     Ongoing assessment of product labeling adequacy
  •     Development of post-marketing safety surveillance programs
  •     Automated management of regulatory databases
  •     U.S. regulatory point of contact for several domestic and international manufacturers
  •     Evaluation and Preparation of Quarterly and Annual Reports

 

Legal Support

PDG is your Regulatory Expert

PDG provides litigation support and research, as well as expert testimony to the legal community for qualifying cases. Our commitment to data-driven analyses forms the foundation for our selection of assignments.

PDG staff works in partnership with members of the legal community to ensure those involved in litigation have a thorough knowledge of the scientific and regulatory matters at issue. Our solid credibility and meticulous preparation has earned trust for PDG at both FDA and in the courtroom.

PDG's experience in pharmaceutical industry litigation includes participation in both civil and criminal cases on the state and federal level involving contractual disputes, patent, trademark and copyright proceedings, criminal litigation, product liability cases, product failure, failure to warn cases and anti-trust related issues.

PDG's expertise in litigation support services includes, but is not limited to:

  • Document review and summarization
  • Preparation of databases and regulatory chronologies
  • Analysis of safety databases
  • Maintenance of complex, technical litigation databases
  • Preparation of expert reports
  • Deposition testimony
  • Trial testimony
  • Support and coordination of scientific and regulatory experts

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