Regulatory Affairs Services Supporting Successful Outcomes End-To-End

We help clients achieve positive regulatory outcomes using a scientific approach as the driver of success. As the world’s leading provider of regulatory consulting services, we support our clients from pre- through post-approval for both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Our aim is to make your business succeed. ProPharma Group’s experienced team commands a breadth and depth of knowledge pertaining to the FDA and EMA regulatory frameworks and can work with you to accomplish your regulatory and business objectives. We develop regulatory strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.

ProPharma Group continues to build upon our strong foundation of regulatory science with acquisitions that further globalize and deepen our service capabilities. Our integrated team of specialists has grown through uniting leading regulatory affairs companies such as the former Xendo Life Sciences and Sofus Regulatory Affairs, as well as The Weinberg Group and Southwood Research.

Our veteran team has over 37 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies. Explore all the ways that ProPharma Group can support your product pipeline throughout the entire product lifecycle:

Some links below will take you to other ProPharma Group websites for more detailed service offerings.

FDA Services: Drug Development

From developing and executing your regulatory strategy to obtaining NDA approval, our regulatory and scientific knowledge combined with our experience and history of working with the FDA enables us to advance your product successfully.

FDA Services: Medical Device Development

From concept development through FDA approval and the Agency’s post-marketing requirements, our team of specialists are highly qualified to assist you in all aspects of device regulation throughout the product lifecycle.

EMA Services: Pre-Authorization

Interacting with the EMA and obtaining the Agency’s approval can be a daunting task; we are here to help you every step of the way.

EMA Services: Regulatory Operations

After your data has been gathered and your submission has been compiled, if it is not submitted appropriately, all of your hard work could fall short and fail. We assist with all EMA communication and interaction to achieve successful outcomes.

EMA Services: Post-Authorization

We understand your work does not end after EMA approval has been obtained, so neither does ours. Our expertise and experience extends well into the post-authorization phase to continue and ensure all EMA requirements are completed appropriately.

The ProPharma Group Advantage

Drugs, Biologics, and Medical Devices

Our experts specialize in all facets of pharmaceutical and medical device development and regulation

FDA and EMA Expertise

Using our novel approach which combines deep scientific knowledge and extensive regulatory experience, we help clients achieve successful outcomes with regulators within the FDA and EMA

Full Lifecycle Support

From early stage development through the approval and commercialization of your product, our experts can assist with all your regulatory needs across the entire product lifecycle

A Global Team of Trusted Experts

Are you in the process of developing an FDA or EMA regulated product? Our experienced team of specialists can help you achieve successful regulatory outcomes in the most expeditious way possible to help you realize the value of those outcomes sooner.

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Overview

FDA Services: Drug Development

FDA Services: Medical Device Development

EMA Services: Pre-Authorization

EMA Services: Regulatory Operations

EMA Services: Post-Authorization

Overview

Compliance

Product and Process Lifecycle Management

Commissioning, Qualification, and Validation

Engineering and Project Management

Clinical Consulting

Specialized Services

Overview

Clinical PV

Postmarketing PV

Overview

Global Medical Information Contact Centers

Medical Writing and Content Management

Other MI Services

Regulatory Affairs Services Supporting Successful Outcomes End-To-End

FDA Services: Drug Development

FDA Services: Medical Device Development

EMA Services: Pre-Authorization

EMA Services: Regulatory Operations

EMA Services: Post-Authorization

The ProPharma Group Advantage

Drugs, Biologics, and Medical Devices

FDA and EMA Expertise

Full Lifecycle Support

A Global Team of Trusted Experts

EVENTS

September 1-4

September 17-18

September 21-24

Need Help Navigating the Dynamic Regulatory Market to Bring Your Product Concept to Market?

Gain an Industry Edge With Expertise From ProPharma Group