Regulatory Information Management Systems Software (RIMS) are centralized platforms designed to support and streamline Regulatory Affairs teams and operations. RIMS helps in the creation, organization, submission, and archival of regulatory information in regulated...
In this blog, we sat down with Daria Fellrath, Senior Manager of Global Talent and Culture Management at MMS, to discuss how important it is to align a global team, engage with colleagues, and foster human connections across organizations. Daria’s leadership and...
The Clinical Trials Information System (CTIS) is a single portal for European Union (EU) competent authority and ethics submissions for clinical trial applications (CTAs) across EU member states. The system represents the actualization of the EU Clinical Trials...
With all new regulations like Health Canada-PRCI, EMA Policy 0070 and EU-CTR requiring the publication of clinical information, it’s important to understand what is considered company confidential information (CCI) and how to protect the information being shared with...
The PDUFA VII Commitment Letter builds on the programs supporting the use of Real-World Evidence (RWE) in regulatory decision-making begun under PDUFA VI. Specifically, the following initiatives incorporating RWE have been incorporated into PDUFA VII: Pilot Advancing...
Sponsors receive FDA feedback and advice on their drug development program via formal FDA meetings. These meetings allow Sponsors to learn the FDA's current thinking on a specific topic and to amend their development program based on FDA's recommendations...
Patient safety remains at the forefront of the FDA's intentions to continue and enhance existing drug safety programs and develop new ones under PDUFA VII. Commitment to Enhanced Communication on Risk Management Activities During Review Some of the planned...
FDA establishes numerous enhancements to product quality and chemistry, manufacturing, and controls (CMC) approaches in PDUFA VII to facilitate timely access to safe, effective, and innovative new medicines for patients, including: product quality reviews; CMC...
Quality control (QC) is an essential step in developing regulatory documents. However, not all QCs can be done in a standard way or on usual documents. In this blog, we’ll discuss how to set yourself up for success when you need bespoke QC. What is Quality Control...