Xendo, Sofus Regulatory Affairs, and SOLUTIONS in Health are now ProPharma Group. Learn more.

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.

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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.

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Company Blog

January 8, 2019
Innocent Until Proven Guilty: Hypothesis Test
If you always make the right decision, this article is not for you. Learn… Read More
November 29, 2018
Industry Poll: How Can Your GMP Auditing Program Be Most…
Expert insight into how you can take steps to best improve your GMP auditing… Read More
November 15, 2018
The Important Role of Advanced Therapy Medicinal Products
Today on the blog, a personal perspective from a colleague on the impact and… Read More
More Articles

UPCOMING Events

January 28, 2019
DIA Pharmacovigilance and Risk Management Strategies Conference
Join us at DIA’s Pharmacovigilance and Risk Management Strategies Conference for context, background,... Read More
February 05, 2019
DIA Europe 2019
Join ProPharma Group, and more than 2,000 attendees at DIA Europe 2019! This event provides a chance to learn... Read More
February 18, 2019
SCOPE – Summit for Clinical Ops Executives
SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-de... Read More
All Events
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