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.

View Services
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.

View Services

Company Blog

May 30, 2019
FDA’s Top 483 Observations for 2018: A Reflection of Industry’s…
Understanding industry’s compliance direction, and how this data can help evaluate the capability and… Read More
May 9, 2019
Meet the Expert: Marc Klinkhamer
Meet Marc Klinkhamer, a Principal Consultant and medical device expert based out of ProPharma… Read More
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
More Articles

UPCOMING Events

June 28, 2019
Dutch Biotech Event 2019 – HollandBIO
Whether you’re working at a biotech startup, scale-up, runner-up or an established multinational, you do not... Read More
July 25, 2019
ISPE San Francisco 25th Annual Fun Day
Our team looks forward to this event each year, and we can’t wait to celebrate the 25th anniversary with... 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
All Events
Contact Us