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Best Practices for Completing FDA Forms

FDA has more than 300 forms to collect and receive information across a wide range of drug development subjects. In the case of electronic Common Technical Document (eCTD) submissions, there is a specific form (based upon submission type) to be completed and included with every eCTD sequence you submit. These fillable PDF forms provide FDA … Continued

Certara Launches New Synchrogenix™ Writer Software to Accelerate the Regulatory Submission Process

Cloud-based and validated regulatory software automates and advances quality of patient narratives Princeton, N.J., September 30, 2021 – Certara, a global leader in biosimulation, today announced the launch of Synchrogenix™ Writer, a new regulatory SaaS product that expedites the authoring and review of patient narratives. Patient narratives describe adverse events or adverse drug reactions and … Continued

Understanding Key Components of a Clinical Evaluation

In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting medical devices. This guideline was published and went into immediate effect without a transition … Continued

How Project Management & Technology Streamline the Patient Narrative Process

Utilizing Synchrogenix™ Writer streamlines the patient narrative process from start to finish. Production is made faster and easier with the use of technology and skilled narrative leads, writers, and Quality Control (QC) reviewers. We partner with Sponsors at kickoff and guarantee we have all components of the process covered through to submission.  We share our full process with our partners, so that you’ll … Continued

The Past and Future of Drug Safety Narratives

The process of safety narrative writing has changed drastically over the years. But despite all these changes, the goal remains to deliver a high volume of narratives describing key events, the details of which are important for drug safety reporting. As technology is evolving, the process of developing patient safety narratives is also evolving. The … Continued

Thought Leadership Series: Leveraging FDA expedited review programs

 August 25, 2021 at 2:00 p.m. ET The U.S. FDA offers four distinct programs to speed the development and availability of drugs that address an unmet medical need in the treatment of a serious or life-threatening conditions: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Additionally, other programs, such as the Regenerative Medicine Advanced … Continued

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