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

August 14, 2019
Meet the Expert: Tom Oakley
Meet Tom Oakley, a leader of the Southwood Research team helping companies navigate the… Read More
July 29, 2019
Get the Most Out of Your GMP Effectiveness Checks
What exactly is the effectiveness check, and how do you apply it adequately? Read More
July 9, 2019
Meet the Expert: Terry Hietpas
Meet PV expert Terry Hietpas, supporting clients out of our Saint Paul, Minnesota office Read More
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UPCOMING Events

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
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
September 10, 2019
World Drug Safety Congress Europe
The World Drug Safety Congress Europe will bring together 550+ drug safety, pharmacovigilance, data analytics,... Read More
All Events
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