FDA Regulatory Consulting

The World's Leading FDA Regulatory Consultancy

Healthcare professionals in lab coats conversing around a table

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.

Gradient Image

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

Checkmark icon

Regulatory Strategy

Regulatory Strategy

Authority Meetings icon

FDA Meetings

FDA Meetings

Submissions icon

FDA Submissions

FDA Submissions

Regulatory Sciences icon

Nonclinical Development

Nonclinical Development

Clinical Research Solutions icon

Clinical Development

Clinical Development

Regulatory CMC icon

Regulatory CMC

Regulatory CMC

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.

Hand writing on paper

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
Business worker with virtual attendees in conference room

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:

Hands holding pens working over layers of papers and post it notes

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.

Two women in lab coats reviewing a laptop in a laboratory

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.

Woman focused on injecting test tube

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.

Lab tech holding beaker with fluid reviewing a laptop

Additional FDA Regulatory Consulting Services Include:

Hand writing on chart with a pen

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.

Patient being scanned using high tech medical device

Regulatory Science Experts

  • Matthew Weinberg Bio Photo

    Matthew Weinberg

    President, Regulatory Sciences

  • Steve Jensen Bio Photo

    Steve Jensen

    Executive Vice President, Head of U.S. Regulatory Sciences

  • Eric Fish Bio Photo

    Eric Fish

    General Manager, NDA Partners

  • Carrie Rabe Bio Photo

    Carrie Rabe

    Vice President, Nonclinical Regulatory

  • Philip Simonson Bio Photo

    Philip Simonson

    Senior Vice President, CMC Regulatory Sciences

    View Bio

  • Nita Patel Bio Photo

    Nita Patel

    Executive Director, Global Regulatory &, CMC Strategic Expert

  • Clarence Young Bio Photo

    Clarence Young

    Senior Vice President, Clinical US Regulatory Sciences

  • Daniel Solorio Bio Photo

    Daniel Solorio

    Senior Vice President, Regulatory Program Management

Philip is the Senior Vice President for CMC Regulatory Sciences at ProPharma.  He has over 30 years of experience executing global regulatory strategies in all phases of drug development including life-cycle management. He is also accomplished in R&D program management and in the successful commercialization of enabling drug delivery technologies.  Prior to joining ProPharma, he spent more than 20 years in industry with Parke-Davis, Pfizer & Cephalon and most recently served as Vice President, Global Regulatory Affairs for ICON plc. 

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

PMA Post-Approval Study Considerations

October 7, 2024

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.

What is a Clinical Evaluation Report (CER)?

September 30, 2024

What is a Clinical Evaluation Report (CER)?

Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.

Navigating Uncertainty with the FDA LDT Rule

September 26, 2024

Navigating Uncertainty with the FDA LDT Rule

Explore the FDA's 2024 Final Rule on Laboratory Developed Tests (LDTs), outlining a four-year phaseout of enforcement discretion, its impact on labs, and compliance strategies.

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

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.

ProPharma Receives 2024 CRO Leadership Award

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.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

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.

ProPharma Receives 2024 CRO Leadership Award

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.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

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.

ProPharma Receives 2024 CRO Leadership Award

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.

Previous Post Arrow Next Post Arrow
ProPharma Honored in the 2024 Clinical Trials Excellence Awards

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.

ProPharma Receives 2024 CRO Leadership Award

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.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Previous Award Arrow Next Award Arrow
PMA Post-Approval Study Considerations

October 7, 2024

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.

What is a Clinical Evaluation Report (CER)?

September 30, 2024

What is a Clinical Evaluation Report (CER)?

Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.

Navigating Uncertainty with the FDA LDT Rule

September 26, 2024

Navigating Uncertainty with the FDA LDT Rule

Explore the FDA's 2024 Final Rule on Laboratory Developed Tests (LDTs), outlining a four-year phaseout of enforcement discretion, its impact on labs, and compliance strategies.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow