Pharmaceutical Development Group, Inc.
Pharmaceutical Development Group (PDG) offers expert FDA regulatory consulting and strategic drug development services. They partner with life sciences companies to navigate complex regulatory pathways, ensuring product safety, efficacy, and commercial success.
Pharmaceutical Development Group (PDG), a subsidiary of Biotech Research Group Corporation, provides comprehensive FDA regulatory consulting and strategic drug development services. With extensive experience dating back to 1999, PDG assists drug and medical device companies in navigating the complexities of the FDA, from early-stage development through post-launch activities. Their expertise spans a wide range of services, including Pre-IND meetings, IND/SPA submissions, clinical trial design, NDA submissions (505(b)(1)/505(b)(2)), and generic drug applications (505(j) ANDAs). PDG also offers specialized consulting for medical devices, covering submissions like 510(k) and PMA, as well as facility inspection readiness and mock audits. PDG's team comprises seasoned professionals, including former FDA regulatory scientists and chemists, who leverage their deep understanding of regulatory requirements to maximize the safety, efficacy, and commercial value of their clients' products. They are dedicated to serving as long-term regulatory partners throughout the product lifecycle, ensuring compliance with cGMP, QSR, and other relevant international standards.
About
**Who they are**
Pharmaceutical Development Group, Inc. (PDG) is a subsidiary of Biotech Research Group Corporation, offering expert FDA regulatory consulting and strategic drug development services. They have been engaged with the FDA in meetings and negotiations on behalf of clients since 1999.
**Expertise & scope**
* Navigating complex regulatory pathways for product safety, efficacy, and commercial success.
* Strategic drug development services, including Pre-IND meetings, Investigational New Drug Applications (IND), Special Protocol Assessments (SPA), clinical trial design, and Pre-NDA meetings.
* Support for various submission types, including 505(b)(1)/505(b)(2) NDAs and 505(j) ANDAs for generic drugs.
* Guidance on nonprescription drugs (OTC) and compliance with regulations like the Dietary Supplements Health and Education Act of 1994 (DSHEA).
* FDA facility inspection readiness and mock audits, covering quality control, quality assurance, document control, and complaint handling procedures.
* Preparation for FDA inspections, including mock audits of third-party facilities (vendors, suppliers, CROs, CMOs) and team training on inspection protocols.
* Addressing QSR, cGMP, Part 11, ICH, ISO 13485, Health Canada (CMDCAS), and European Union (MDD) compliance.
* Assistance with FDA Establishment Registration for drug producers and manufacturers.
* Support for dietary supplement manufacturers to ensure products are safe and accurately labeled, including completing necessary documentation on the Safety Report Portal.
* Global regulatory affairs and pharmaceutical consulting services for developers seeking a U.S. presence, including those from Europe and Asia.
**Reputation / proof points**
* Serving as FDA Pharmaceutical regulatory consultants since 1999.
Pharmaceutical Development Group, Inc. (PDG) is a subsidiary of Biotech Research Group Corporation, offering expert FDA regulatory consulting and strategic drug development services. They have been engaged with the FDA in meetings and negotiations on behalf of clients since 1999.
**Expertise & scope**
* Navigating complex regulatory pathways for product safety, efficacy, and commercial success.
* Strategic drug development services, including Pre-IND meetings, Investigational New Drug Applications (IND), Special Protocol Assessments (SPA), clinical trial design, and Pre-NDA meetings.
* Support for various submission types, including 505(b)(1)/505(b)(2) NDAs and 505(j) ANDAs for generic drugs.
* Guidance on nonprescription drugs (OTC) and compliance with regulations like the Dietary Supplements Health and Education Act of 1994 (DSHEA).
* FDA facility inspection readiness and mock audits, covering quality control, quality assurance, document control, and complaint handling procedures.
* Preparation for FDA inspections, including mock audits of third-party facilities (vendors, suppliers, CROs, CMOs) and team training on inspection protocols.
* Addressing QSR, cGMP, Part 11, ICH, ISO 13485, Health Canada (CMDCAS), and European Union (MDD) compliance.
* Assistance with FDA Establishment Registration for drug producers and manufacturers.
* Support for dietary supplement manufacturers to ensure products are safe and accurately labeled, including completing necessary documentation on the Safety Report Portal.
* Global regulatory affairs and pharmaceutical consulting services for developers seeking a U.S. presence, including those from Europe and Asia.
**Reputation / proof points**
* Serving as FDA Pharmaceutical regulatory consultants since 1999.
Additional information
PDG emphasizes a posture of readiness to react and respond to client needs and regulatory urgencies 24 hours a day, 7 days a week. They are equipped to handle unexpected emergencies such as receiving an FDA Form 483 or Warning Letter, potential recalls, or other sudden situations. Their consulting team includes industry experts with access to former FDA inspectors, enabling them to identify potential problem areas that could lead to regulatory actions. They also prepare clients for the presentation of documents, communication during inspections, and the assignment of efforts to address various aspects of an FDA inspection.
Key Highlights
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Serving as FDA Pharmaceutical regulatory consultants since 1999.
Source
“As FDA Pharmaceutical regulatory consultants since 1999, PDG® is continuously engaged with FDA in meetings and negotiations on behalf of our clients.”
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Offers 24/7 readiness for regulatory urgencies and emergencies.
Source
“At PDG, we maintain a posture of readiness to react and respond to your needs and regulatory urgencies 24 hours a day, 7 days a week.”
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Provides mock FDA audits and gap analyses covering multiple compliance standards.
Source
“The resulting gap analyses address QSR, cGMP, Part 11, ICH, ISO 13485, Health Canada (CMDCAS) and European Union (MDD) compliance, among other standards.”
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Supports global clients, including European and Asian drug developers, seeking a U.S. market presence.
Source
“We are global in providing FDA regulatory affairs and Pharmaceutical consulting services to European, Indian and other Asian drug developers seeking a U.S. presence.”
Certifications & Trust Signals
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Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
Source
“Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.”
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PDG® is a federally registered service mark of Pharmaceutical Development Group, Inc.
Source
“PDG® is a federally registered service mark of Pharmaceutical Development Group, Inc.”
Buyer Snapshot
Best for
- Companies seeking to navigate complex FDA regulatory pathways.
- Life sciences companies requiring strategic drug development support.
- Manufacturers needing assistance with FDA inspections and compliance.
How engagement typically works
- Responsive and ready to address urgent situations 24/7.
- Partnership approach to guide clients through regulatory processes.
- Leveraging industry experts and former FDA inspectors for insights.
Typical deliverables
- FDA regulatory consulting reports and strategies.
- Mock FDA audit gap analyses.
- Guidance on IND, NDA, and ANDA submissions.
- FDA Establishment Registration support.
Good to know
- Best when requiring expert guidance on U.S. FDA regulations for drug development and compliance.
HQ:
US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Inspection Support:
Yes
Product Type:
devices
Additional us_agent_fda Details
Product Types
Drugs, Dietary Supplements, Medical Devices, Cosmetics, Packaged/Repacked Food, Tobacco, Vaccines
Registration Support
Yes
Recall Support
Yes
Inspection Support
Yes
Emergency Contact24x7
Yes
