Regulatory Affairs Services

You Don’t Have to Understand Global Regulations. We Do.

PROPHARMA GROUP REGULATORY AFFAIRS SERVICES

In every pharmaceutical and biotechnology project, mastering the regulatory steps is key for a smooth development pathway and final submission to authorities, saving money and appropriate time to market. By outsourcing your global project to ProPharma Group, you even can create business opportunities all over the world.

We transform vast, global regulatory experience and in-depth business intelligence into new opportunities for you. By treating your regulatory affairs as a business critical factor, we identify possibilities that may positively influence your project’s path to authorization – or the product’s lifecycle once approved. That is more than good business; it is intelligent business.

We guide you through the scientific and regulatory requirements and provide high-level RA services in all phases of a product’s lifecycle: from early-stage development to marketing authorization and post-approval requirements. We provide a complete range of consulting services needed for the successful preparation, submission, and support of pharmaceutical and biopharmaceutical dossiers.

Services Throughout the Product Lifecycle

COMMERCIALIZATION

These comprehensive services allow us to partner with clients who require large-scale manufacturing and postmarketing surveillance support.

View Services
CLINICAL

Whether you are in Phase I, Phase II, or Phase III, ProPharma Group has wide breadth of services catered to your unique, product development and pre-approval scale up needs.

View Services

Company Blog

July 9, 2019
Meet the Expert: Terry Hietpas
Meet PV expert Terry Hietpas, supporting clients out of our Saint Paul, Minnesota office Read More
June 27, 2019
Gene and Cellular Therapies: Five Keys to Regulatory Success
We are living through a medical revolution. Advances in gene therapy, cell‑based… Read More
June 25, 2019
Deviations: Beyond the Basics
Move beyond the basics of deviations with recommendations from the experts. Read More
More Articles

UPCOMING Events

July 25, 2019
ISPE San Francisco 25th Annual Fun Day
Our team looks forward to this event each year, and we can’t wait to celebrate the 25th anniversary with... Read More
August 15, 2019
ISPE Midwest Chapter 2019 Golf Tournament
Join us for this annual golf tournament and networking opportunity! Connect with a ProPharma Group team member... Read More
September 04, 2019
Cannabis Science Conference West
Join us at the Cannabis Science Conference, the world’s largest and most technical cannabis science expo... Read More
All Events
Contact Us