Synchrogenix takes pride in its role as an innovator and educator in the regulatory strategy, science, and services industry. In an effort to advance the industry as a whole, and encourage eCTD adoption, our thought leaders often collaborate on educational white papers. These white papers elaborate on current consequential topics affecting stakeholders in our industry. Please browse the list of our most recent educational regulatory strategy, science and services white papers. To request a white paper, click on the name of the white paper below.
Regulatory Strategy, Science and Services Educational White Papers Available for Download
For small bio-pharmaceutical companies, the fastest and most efficient way to transition from paper-based to eCTD submissions is outsourcing. Although making the decision to switch is easy, companies still need to develop a submission and document management strategy that will address both short-term and long-term goals.
The European Medicines Agency (EMA) Policy 0070 guidance was initially issued in 2016 and since then has undergone several iterations. The evolving guidance adds complexities to the Marketing Authorisation Application submission process, challenging organizations to be agile with their teams and processes as they establish best practices and stay current with policy changes. Although Policy 0070 continues to be expanded for openness and greater data utility, many aspects of the disclosure process remain undefined, leaving sponsors to work through complex issues on their own. Further updates are expected as the EMA incorporates additional requirements such as advanced anonymization techniques and dataset de-identification. Avoiding pitfalls, ensuring compliance, and keeping teams engaged within the changing paradigm is challenging but critical to success.
Product development has become more complex and multi-layered. Shifts in regulatory requirements, globalization, payer requirements, and new technologies are putting pressure on companies to do more with fewer resources. As leadership teams rise to meet the new bar, they are able to incrementally improve budgets and timelines by streamlining individual functional output within established frameworks of ownership. However, extra effort in isolation does not typically create significant overall gains.
In our experience, substantial time and cost efficiencies require strategic re-thinking of established paradigms, bridging of functional lines, and creation of new technology-enabled approaches across the framework. We will use an example of a large narrative project to demonstrate transformative power of this approach.
The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Clinical trials are essential to developing new therapies for patients. But the individuals that participate in those trials put themselves at risk. In return, the medical community has an ethical obligation to disclose clinical trial information and create transparency around the data. These steps are critical for increasing trust between the public and the industry.
Synchrogenix was an integral part of the first ever successful Modified Risk Tobacco Product Application (MRTPA). That submission was officially accepted for review by the FDA in July 2014.