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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

March 15, 2019
Assumed Brexit & Batch Control Testing Site In UK
Understanding the European Commission (EC) notice on the European rules for batch control testing… Read More
March 10, 2019
ProPharma Group Announces Acquisition of Southwood Research
Southwood Research is a leading provider of pre-approval regulatory science services to the pharmaceutical… Read More
March 6, 2019
Health Apps and the Requirements Imposed By the Law
Understanding medical apps and necessary considerations based on European regulatory requirements. Read More
More Articles

UPCOMING Events

March 27, 2019
MassBIO Annual Meeting
This year’s Annual Meeting is now the State of Possible Conference where we’ll celebrate what’s poss... Read More
April 01, 2019
ISPE Europe Annual Conference
Join the European pharmaceutical industry’s top decision makers and influencers at the ISPE Europe Annual Co... Read More
April 02, 2019
Future of Health
Meet ProPharma Group at the Future of Health! Future of Health is European largest, hottest and most interact... Read More
All Events
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