FDA Regulatory Consulting
The World's Leading FDA Regulatory Consultancy
Our goal is to help your business succeed by working with you to streamline the FDA regulatory process. ProPharma’s team of science- based regulatory consultants commands an unparalleled breadth and depth of knowledge pertaining to FDA’s regulatory framework and can work with you to accomplish your business objectives. Our FDA consultants develop detailed regulatory strategies for your product, providing a clear path forward through all the critical FDA milestones.
All of the members of our staff have been through multiple submissions and know how to use science to help drive your product through the regulatory process. In the past 15 years, all of our submissions have been successful. In every therapeutic area, in every type of product, our clients have gotten the feedback they wanted and the ability to move forward. From INDs, to BLAs, to priority vouchers and every type of FDA meeting, clients working with us have achieved their goals.
Explore all the ways that ProPharma’s Regulatory Sciences team can assist with all of your pharmaceutical regulatory affairs needs, supporting your product pipeline throughout the entire product lifecycle.
Are you ready to achieve your regulatory goals?
Contact us today to learn about our 40-year track record of success with FDA and how we can help you get to the next regulatory milestone.
Our FDA Product Development & Regulatory Affairs Consulting Services
Regulatory Strategy & Gap Analysis Support
Your goal is to get your product approved and on the market in the most efficient way possible. To make this happen, you need a solid and effective regulatory strategy. Our team of Regulatory Sciences experts will work with you to develop a comprehensive strategy that will provide confidence in the forecast of key FDA milestones, necessary documentation, overall effort, cost, and a plan of action.
FDA Meeting Consulting
When conducted effectively, you should leave an FDA Meeting with answers to critical questions and an understanding of the Agency’s expectations. To achieve these goals, your meeting must be carefully planned and flawlessly executed. ProPharma’s team of FDA Meeting consultants has significant experience planning and executing FDA Meetings, including:
- Pre-IND Meetings
- End of Phase 2 (EOP2) Meetings
- Pre-NDA Meetings
- Pre-BLA Meetings
- FDA Advisory Committee Meetings
- Type A, B, C, and D Meetings
FDA Submissions
ProPharma’s Regulatory Sciences team offers expert guidance and FDA submission support throughout the entire product development and launch processes. With over 40 years of experience, we will plan and coordinate every detail of a clear and complete FDA submission. We’ll utilize our extensive regulatory and scientific experience, coupled with our strong relationship with FDA, to optimize the entire submission process. We provide regulatory affairs consulting services for key FDA regulatory submissions, including:
- Investigational New Drug (IND) applications
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Orphan Drug Designation (ODD) applications
- Biologics License Applications (BLAs)
- Investigational Device Exemptions (IDEs)
- 510 (K) submissions
- De Novo submissions
- Q submissions
- Pre-Market Approval (PMA) applications
Nonclinical Drug Development
Nonclinical studies begin well before a Sponsor’s first interaction with FDA and span throughout a product’s development. Having a robust nonclinical development program can help you avoid spending time and resources on studies that fail to address FDA’s issues of concern, and thus may need to be repeated.
Our nonclinical consultants help maximize your potential for success by designing pharmacology, pharmacokinetics, and toxicology programs that are appropriate to support the intended indication, route of administration, and duration of treatment for your product.
Clinical Development Consulting
Without the right clinical study data and an understanding of the relationship, New Drug Application (NDA) submissions may be perceived as incomplete or unsubstantiated. This can lead to unexpected delays in your product’s development, a need for additional studies, and financial implications. Our team of clinical consultants will help you implement a solid PK/PD program to facilitate a successful development program which will streamline FDA’s NDA review process.
Regulatory CMC Consulting
Chemistry, Manufacturing, and Controls (CMC) begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development lifecycle. Our team of regulatory CMC consultants are scientists first and foremost, and our CMC consulting services can be tailored to meet your unique needs throughout the entire development lifecycle, from candidate selection through post approval and beyond.
Additional FDA Regulatory Consulting Services Include:
Regulatory Operations
Regulatory Operations is the support function responsible for handling all logistics associated with submitting an application to FDA. This includes document preparation, submission, and tracking of submissions to ensure they are compliant with all of FDA’s requirements from a technical perspective.
The nature of the role of Regulatory Operations has evolved significantly over the last decade. Since the FDA transitioned to electronic submissions, the role of Reg Ops teams has gone from a “nice to have” to a necessity. Today, there is a higher premium placed on having a Regulatory Operations team that is technically proficient and able to anticipate potential validation errors and rejection criteria, because there is increasing scrutiny on documents being received in the format the FDA prefers.
Medical Devices & Combination Products
As technology continues to improve and drive the world we live in, medical devices and their associated technologies are evolving as well. Although these developing technologies have led to significant advancements in modern medicine, they have also made it increasingly more challenging from a regulatory perspective. Regardless of where you are in the development or approval of your medical device, we can help with all of your FDA-related needs.
Regulatory Science Experts
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Matthew Weinberg
President, Regulatory Sciences
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Steve Jensen
Executive Vice President, Head of U.S. Regulatory Sciences
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Eric Fish
General Manager, NDA Partners
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Carrie Rabe
Vice President, Nonclinical Regulatory
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Philip Simonson
Senior Vice President, CMC Regulatory Sciences
View Bio
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Nita Patel
Executive Director, Global Regulatory &, CMC Strategic Expert
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Clarence Young
Senior Vice President, Clinical US Regulatory Sciences
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Daniel Solorio
Senior Vice President, Regulatory Program Management
Matthew Weinberg
Steve Jensen
Eric Fish
Carrie Rabe
Philip Simonson
Nita Patel
Clarence Young
Daniel Solorio
The World's Leading Regulatory Consultancy
Interested in learning how we can help with your regulatory needs? Contact us today to learn about our track record of success with the FDA over the last 40 years and discuss how we can help you get to the next regulatory milestone and achieve your regulatory goals.
News & Insights
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PMA Post-Approval Study Considerations
Learn the essential considerations for conducting Post-Approval Studies (PAS) for medical devices, including protocols, timelines, and reporting requirements to ensure compliance with FDA regulations.
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ProPharma Names Dawn Sherman Chief Executive Officer
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ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
June 13, 2024
ProPharma Receives 2024 CRO Leadership Award
ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.
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The Cost of Poor Project Management
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ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights