UK Regulatory Advisor Services

Your UK Regulatory Experts

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.

50+ Regulatory Strategies Developed Every Year

Each year, we work with countless clients helping them achieve their regulatory goals in various ways. The regulatory strategy is a critical first step in obtaining FDA approval and each year we develop and execute an average of 50+ regulatory strategies for our client - that means our team is completing at least one regulatory strategy each week!

1,000s of Successful Interactions with FDA

Over the last 40 years we have established a long-standing relationship with FDA built upon our track record of success when meeting with the Agency. Our team meets with FDA an average of once every week. Over the years we have conducted 1,000s of successful FDA meetings

99+% Successful FDA Submissions

Over the last 15 years, almost every application we have submitted to FDA has achieved the desired outcome, including INDs, NDAs, BLAs, ODDs, Priority Review, etc.

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

FDA Q-SUB

FDA Submissions

Nonclinical Development

Clinical Development

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

Martin Sprunck

Principal

Dan Mitchell

Assistant Manager

Noah Patterson

Programming Editor

Tess Anderson

Art Director

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.