Clinical Research Solutions
Implementing eQMS in a Regulated Environment
Everything we do today is traceable. The integrity of the data, documents and decisions needs to be defendable and consistent. Electronic Quality Management Systems (eQMS) are an effective way to...
Clinical Research Solutions
Meet the Expert: Maurice Weijers
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Clinical Research Solutions
FDA Announces All-Time Low User Fee Rates for Priority Review Vouchers (PRVs)
On Thursday, September 30th, FDA announced its user fee rates for fiscal year 2022 for Sponsors using the priority review vouchers (PRVs) for the following: Tropical diseases Material threat medical...
Clinical Research Solutions
Four Benefits of Requesting an FDA Pre-IND Meeting
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
Clinical Research Solutions
Development with the End in Mind – Overcoming Early-Phase Challenges
A drug must be safe and effective. Manufacturing of a drug product should consistently yield a predetermined quality. These are the undisputed goals for commercialization of a drug within our...
Regulatory Sciences
Filing Using Registry-Based Studies? EMA Issues Draft Guidance
Recruiting clinical studies in a niche disease area can be challenging, but disease registries can provide the solution. The European Medicines Agency (EMA) has issued draft guidance on how...
Clinical Research Solutions
Gene and Cellular Therapies: Five Keys to Regulatory Success
We are living through a medical revolution. Advances in gene therapy, cell‑based therapies and tissue engineering offer real hope for patients with a range of debilitating diseases. The FDA, EMA and...