With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. Working to bring these valuable new therapies to patients, sponsors engaged in strategic development...
Expertise: Consulting 225 results
During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a...
The Marketing Authorization (MA) holder for a treatment for onychomycosis, having previously secured regulatory approval in several markets, sought to introduce the product to the European market. Completion of the Marketing Authorization Application (MAA) required utilization of the Active Substance...
Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE)...
The technology transfer of a manufacturing process to a contract development and manufacturing organization (CDMO) is a key step on the road to developing and commercializing biopharmaceutical products. Successfully executing this step is critical to clearing regulatory expectations, avoiding production...
A quality electronic Trial Master File (eTMF) is essential to the product development and approval process, as it is the foundation for clinical trial inspections by competent authorities. eTMFs for drug, biologic, and medical device trials should be actively managed...
Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access...
One of the specialized capabilities in Premier Research's toolbox is coordinating the Active Substance Master File (ASMF) submission process on behalf of sponsors. The ASMF procedure (formerly known as the European Drug Master File [EDMF] procedure) has in recent years...
Preparing for regulatory submissions and interactions requires seamless communication and continuity across multiple disciplines. While many consulting companies offer regulatory project management as a capability, Premier Research Regulatory Project Managers (PMs) elevate the position by acting a single point of...
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What is 505(b)(2)?
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. A 505(b)(2) NDA contains full safety and effectiveness reports but allows at...