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Digital Transformation
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...
Regulatory Sciences
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...
Quality & Compliance
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...
Quality & Compliance
ProPharma 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,...
Full-Service CRO
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...
Regulatory Sciences
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...
Regulatory Sciences
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...
Quality & Compliance
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
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...
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...
The FDA’s homepage contains an item in the Public Health Focus section from the Office of Communications entitled “Don’t Use Expired Medicine.” Given this mandate, I recall from many years ago the...
What is a PSMF? The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a...
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...
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...