Discover more about ProPharma Group and how our team of industry-leading experts supports clients at every step throughout the product lifecycle to help improve patient health and safety.

Case Studies

Bespoke Regulatory Sciences Teams for Pharmaceutical Companies

Trust ProPharma Group's Regulatory Sciences team for any an all regulatory-related tasks with our Outsourced Regulatory Department.

EMA Approval Under Exceptional Circumstances

How we worked with an approved BLA to fit EU requirements for an MAA submission, resulting in EMA approval.

Growing a Culture of Quality and Compliance

Learn how to realize large savings and improving operational performance with an out-of-the-box enterprise quality management system.

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic.


Navigating the Generic Drug Application and Approval Process

There are several premarket submission pathways for medical devices. Which one is appropriate for your medical device?

Pathways to Market for Medical Devices in the U.S.

Medical devices are regulated by the FDA's CDRH, and there are several premarket submission pathways in the U.S. Which one…



The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.


Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma Group's years of experience navigating the risks, issues, and difficulties…

Expedited Programs Explained: How to Expedite Product Approval in the...

Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find…

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest #quality of services throughout…

Whitepapers & eBooks


What You Need to Know About Regulatory Programs for Expedited...

Differentiating between expedited approval pathways can be tricky. Learn the similarities and differences to help determine the best option(s) for…

Good Science Presented Well Generates Approval

Obtaining marketing approval for a pharmaceutical, biotech, or medical device product requires good data first and foremost. 

How to Compile a Science-Backed New Drug Application (NDA) Submission

Learn how to develop a science-focused submission like an expert with these six tips.

A Guide for Efficacious Data Integrity During COVID-19

With pandemic-related schedule delays, supply chain interruptions, and margin reductions, trustworthy data is critical for quality decision making.


Outsourcing of Medical Information Content Creation: Experience of 100 Clients

Learn how ProPharma Group supported 100 different MI clients to assess the options in relation to their requirements in order…

Evolving EMEA MI Service Models

Learn how ProPharma Group delivered a first-class Medical Information Service in a cost-efficient way.

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Learn how ProPharma Group tackled numerous factors that drove the need to consider a dedicated resource for an outsourced model.

Improving Product Quality During Technical Transfers

Is your product quality at risk during a technology transfer? Make sure you are compliant with applicable regulatory requirements and…


On Demand

October 28, 2021

Navigating the IVDR Medical Device Regulation

What impact will the changing regulations have in the EU and what do we expect for US markets?

November, 10, 2021

How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of the regulatory programs designed to expedite product approval?

FDA Inspection Readiness: Preparing for Success and Overcoming Remediation​

Make sure you are prepared when the FDA resumes normal inspection operations. Exact timing is uncertain, but it's coming.

Where Medical Device Regulation is Headed

In May 2021, MDR took effect in the EU bringing significant regulatory-related changes.

View all Insider Talks >


EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Data Integrity: The Quality of Your Product Depends on The...

Regulatory Agencies Expect Controls to Be in Place

Your Business has Complex Challenges. ProPharma Group has Exceptional Solutions.

We partner with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Contact us to learn how our experienced team can help ensure regulatory and development success throughout the product lifecycle.

Interested in gaining an industry edge? Let us help you stay up to date.

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