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.

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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

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Regulatory Strategy

Regulatory Strategy

authority-meetings

FDA Meetings

FDA Meetings

Submissions

FDA Submissions

FDA Submissions

regulatory-sciences

Nonclinical Development

Nonclinical Development

clinical-research-solutions

Clinical Development

Clinical Development

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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.

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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
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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:

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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.

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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.

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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.

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Additional FDA Regulatory Consulting Services Include:

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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.

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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

  • 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

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

Meet the Expert: David Lough

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Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

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An Overview of the PSMF: Pharmacovigilance System Master File

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The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

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The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

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.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

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Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

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ProPharma Now Certified as Medidata Rave EDC Accredited Partner

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ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

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.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

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 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.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Previous Post Arrow Next Post Arrow
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.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

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