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
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
The Importance of the eCTD Structure for FDA Approval
The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...
A common question when transferring an established process from one facility to another is how to establish that the transferred process is performing equivalently to the original process. Sounds...
When applied rigorously and comprehensively, lean principles can reduce organizational costs while increasing productivity and strengthening the overall quality of submissions What is “Lean” as it...
The research for cancer treatment is moving forward at a rapid pace. We're witnessing a shift from chemotherapy protocols to MTAs (molecularly targeted agents) for immunotherapies in particular....
How to Safely Launch Medical Cannabis Products in Germany
Over the past few weeks the withdrawal of cannabis products from the German market has been a topic which generated a lot of publicity. Therefore, we want to share some tips on how to safely launch...
Pharmaceutical Consulting during Product & Business Development
To stay competitive in the pharmaceutical field, pharmaceutical companies need to have access to legal, product and clinical development, business strategy, and human resources experts. Startups...
With around 2.5 million scientific papers published every year, it is impossible for medical professionals to keep up with all the latest research. Every piece of content is fighting for eyes. To...
Three Steps Towards Complying with Nitrosamine Regulations
All Marketing Authorization Holders (MAH) of medicines for human use are facing what might feel for many, as a new requirement: review their drug products on the possible presence of nitrosamines....
