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

February 14, 2019
Local Person for Pharmacovigilance
Points to consider for Local Person for Pharmacovigilance (LPPV) requirements in different European countries. Read More
January 28, 2019
ProPharma Group Acquires The Weinberg Group
ProPharma Group, a leading provider of compliance services, continues to expand its global presence,… Read More
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
More Articles

UPCOMING Events

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
March 18, 2019
DIA Medical Affairs and Scientific Communications
DIA’s Medical Affairs and Scientific Communications Forum is designed for medical affairs professionals, b... Read More
March 25, 2019
BIO-Europe Spring
Visit ProPharma Group at the BIO-Europe Spring event in Vienna, Austria! Connect with the right partners and b... Read More
All Events
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