Asking the appropriate questions during a pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (pre-IND) meeting can be a valuable component in planning a development program. For companies that...
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Designing an adequate nonclinical program to support the safety of cell or gene therapy products is not always straightforward. In this blog, we will address common questions we receive from our clients and aspects to consider when designing those nonclinical...
Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI.
Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. However, in our experience, the answer is this: it is critical that the nonclinical program provides sufficient data...
Analytical Target Profile The analytical target profile (ATP) concept was first introduced in the ICH Q141 Guideline in 2022. This guideline, which compliments the ICH Q22 Guideline, describes science and risk-based approaches for developing and maintaining analytical procedures suitable for...
In 2022, ICH Q14 officially introduced the enhanced approach1 in analytical development as an alternative path to the minimal approach, the benefits of which are worth exploring further. Analytical data is essential in demonstrating the safety and quality of pharmaceutical...
We spoke with Clinical Research Associates (CRA) to hear what they especially enjoy about working at Premier Research. Here’s what we discovered. I am a true partner to my sites.As a Premier Research CRA, you are a true partner with...
Congratulations! You’ve taken on a new job at Premier Research. This is an exciting step in your career—but you may also be a little nervous. That’s understandable. As many as 1 in 3 people would avoid change if they could...
I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I'll share my insights and key takeaways from the...
Adherence to cGMP regulations assures the identity, potency, purity and quality of biologics or advanced therapeutics and helps ensure adequate control of manufacturing operations. A primary way to demonstrate these attributes for a biologic product under development is through assays....