ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Life Science Outsourcing: Not sure you’re ready to turn over the keys?
It's no secret. To be successful in the life sciences industry you must accomplish a lot – achieve and maintain profitable growth, deliver safe and effective products to patients quickly, manage...
Understanding The Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP), initiated by the International Medical Device Regulators Forum (IMDRF), created a global approach to auditing and monitoring the manufacturing of...
Over recent years relations with data and its weight have changed significantly; consequently, an assessment of Company Data Integrity is becoming one of the key metrics of corporate functionality...
The Human Factor - Preparing Your Device for Usability Testing
When it comes to usability studies, the focus should be on effectively preparing the medical device for use in humans. Whether a Sponsor is conducting formative testing or validation testing, the...
Every industry has a distinct set of obstacles to overcome, but it’s no secret that the life sciences industry encounters more speedbumps than most. Market cycles and product failures are expected,...
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring – Focus on Documenting Test Results & Post-Licensure Considerations
In January 2020, FDA issued a final guidance document on the topic of "Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture...
As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal...
Fundamentals of Data Integrity for ATMP Development
Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to...
