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

April 11, 2019
Utilizing an Agile Framework When Implementing ATMPs
Agile methodology presents a solution for organizations needing to address the timeline constraints of… Read More
April 4, 2019
Meet the Expert: Mary Speckin
Get to know Mary Speckin, Senior Medical Information Specialist at ProPharma Group Read More
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
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UPCOMING Events

May 15, 2019
ISPE Midwest Tech Ed Day
Join us at Arrowhead Stadium for the ISPE Midwest Chapter’s Annual Tech Ed Day! Make plans to attend, an... Read More
September 09, 2019
Cell & Gene Therapy Conference
Meet ProPharma Group at the Cell and Gene Therapy Conference for Bioprocessing and Commercialization, part of ... Read More
November 11, 2019
Biomanufacturing World Summit
The Biomanufacturing World Summit brings together the “who’s who” of pharmaceutical executives and cutti... Read More
All Events
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