ProPharma Group
ProPharma Group is a leading global regulatory sciences consulting firm specializing in FDA regulatory affairs, clinical research, and quality & compliance. They offer end-to-end support across the full product lifecycle for drugs, biologics, medical devices, and diagnostics.
ProPharma Group is a premier global regulatory sciences consulting firm dedicated to improving patient health and safety by helping companies navigate the complexities of drug development and regulatory approval. With extensive expertise across the full product lifecycle, they provide strategic solutions for FDA regulatory consulting, clinical research, quality & compliance, pharmacovigilance, and medical information. Their services encompass a wide range of critical areas, including FDA meeting consulting, regulatory operations, and advertising & promotional review. ProPharma's team of science-based regulatory consultants possesses deep knowledge of FDA's regulatory framework, consistently achieving successful outcomes for clients through detailed regulatory strategies and flawless execution of FDA meetings. They have a proven track record of thousands of successful FDA interactions over 40 years. ProPharma Group also excels in clinical research solutions, offering industry-leading support for multi-phase clinical trials. Their commitment to quality and compliance ensures that products are brought to market efficiently and maintain optimal regulatory status throughout their lifecycle. They partner with clients to streamline the regulatory process, overcome challenges, and achieve business objectives, making them a trusted partner for advancing therapies and ensuring patient access to essential medicines.
About
**Who they are**
ProPharma Group is a global regulatory sciences consulting firm specializing in FDA regulatory affairs, clinical research, and quality & compliance. They offer end-to-end support across the full product lifecycle for drugs, biologics, medical devices, and diagnostics.
**Expertise & scope**
* Develops detailed regulatory strategies for products, providing a clear path through FDA milestones.
* Assists with FDA meeting preparation and execution, including Pre-IND, EOP2, and Advisory Committee meetings.
* Provides Regulatory Operations (RegOps) consulting, focusing on managing and submitting regulatory filings in eCTD format.
* Offers FDA Expert Witness Services, providing strategic support and testimony for litigation involving FDA-regulated products.
* Supports European regulatory development, including strategy, submissions, and CMC planning.
**Reputation / proof points**
* Has a track record of successful FDA submissions, with all submissions being successful in the past 15 years.
* Conducts an average of 50+ regulatory strategies annually.
* Meets with the FDA on a weekly basis and has conducted thousands of successful interactions over 40 years.
ProPharma Group is a global regulatory sciences consulting firm specializing in FDA regulatory affairs, clinical research, and quality & compliance. They offer end-to-end support across the full product lifecycle for drugs, biologics, medical devices, and diagnostics.
**Expertise & scope**
* Develops detailed regulatory strategies for products, providing a clear path through FDA milestones.
* Assists with FDA meeting preparation and execution, including Pre-IND, EOP2, and Advisory Committee meetings.
* Provides Regulatory Operations (RegOps) consulting, focusing on managing and submitting regulatory filings in eCTD format.
* Offers FDA Expert Witness Services, providing strategic support and testimony for litigation involving FDA-regulated products.
* Supports European regulatory development, including strategy, submissions, and CMC planning.
**Reputation / proof points**
* Has a track record of successful FDA submissions, with all submissions being successful in the past 15 years.
* Conducts an average of 50+ regulatory strategies annually.
* Meets with the FDA on a weekly basis and has conducted thousands of successful interactions over 40 years.
Additional information
ProPharma Group emphasizes a strategy-led approach, delivering bespoke solutions tailored to client needs across the entire product lifecycle. Their expertise spans regulatory affairs, clinical research, and quality & compliance, aiming to streamline the pharmaceutical regulatory process. They work with clients to achieve business objectives by navigating complex regulatory frameworks, including those of the FDA and EMA. The firm highlights its extensive experience in developing regulatory strategies and managing interactions with regulatory agencies to reduce time to market and conserve patent life.
Key Highlights
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All FDA submissions have been successful in the past 15 years.
Source
“In the past 15 years, all of our submissions have been successful.”
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Develops an average of 50+ regulatory strategies for clients annually.
Source
“each year we develop and execute an average of 50+ regulatory strategies for our clients”
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Meets with the FDA on a weekly basis and has conducted thousands of successful interactions over 40 years.
Source
“On average, our team meets with FDA on a weekly basis, and has conducted 1,000s of successful interactions with FDA over the last 40 years.”
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Offers end-to-end support across the full product lifecycle for drugs, biologics, medical devices, and diagnostics.
Source
“They offer end-to-end support across the full product lifecycle for drugs, biologics, medical devices, and diagnostics.”
Certifications & Trust Signals
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Recognized as the world's leading regulatory sciences consulting firm.
Source
“ProPharma is the world’s leading regulatory sciences consulting firm”
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Employs a large team of former FDA and senior industry professionals for expert witness services.
Source
“ProPharma's expert witness consulting services deliver unparalleled insight, strategic support, and courtroom-ready testimony from the largest team of former FDA and senior industry professionals in the world.”
Buyer Snapshot
Best for
- Companies seeking comprehensive FDA regulatory support.
- Firms requiring assistance with regulatory submissions and meetings.
- Organizations needing expert witness services for FDA-related litigation.
How engagement typically works
- Collaborative, strategy-focused partnership.
- End-to-end support across the product lifecycle.
Typical deliverables
- Regulatory strategies and gap analyses.
- FDA meeting preparation and execution plans.
- eCTD submission compilation and management.
- Expert witness reports and testimony.
Good to know
- Best when requiring specialized expertise in FDA and European regulatory affairs.
HQ:
US
Languages:
English
Timezones:
EST, PST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Product Type:
devices
Service Types:
US Agent Services, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Drugs, biologics, medical devices, diagnostics
