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.
Yes, there is a light at the end of the long, dark COVID-19 tunnel, and people’s lives will return to a state of normalcy. However, what will the new state of normalcy look like in a post COVID-19...
Clinical Research Solutions
Research and development is a key component in the successful discovery and development of new drugs and medical devices entering the market. It’s also an area of big business, with investments in...
Regulatory Sciences
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...
Much like buying a home as an individual, a company contemplating the acquisition of a new product or business requires a lot of research and fact checking. In both situations, it is critical for the...
Clinical Research Solutions
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...
Clinical Research Solutions
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Quality & Compliance
Now that we have wrapped up the year 2020, it’s important to look ahead and prepare for upcoming regulatory deadlines. It is essential to address these changes and develop a plan, albeit nimble as...
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 improve...
The process of drug development involves clinical and nonclinical studies. Nonclinical studies are considered crucial for understanding the safety of new drugs. Before testing a drug in people,...
Clinical Research Solutions
As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...
The stability of a drug substance or product is a critical attribute for all pharmaceutical products. As such, stability testing is required throughout the drug development phase as well as...
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit...
No one has an ugly baby. At least, no one thinks their baby is ugly. Every new parent thinks their baby is the most beautiful baby of all time. But the unfortunate fact is that there are ugly babies....
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 improve...
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...