Thought Leadership
MDR and IVDR Timeline Overview
In order to take advantage of the MDD extension, device manufacturers must comply with several near-term deadlines and plan for long regulatory turnarounds – the extension provides less time than you might think! Learn how TransPerfect can help you meet the impending MDR and IVDR...
Health Canada's XML Mandate: Pioneering the Future of Pharmaceutical Content
Discover how Health Canada's transition to XML-based templates is reshaping Canadian healthcare content management. Learn about the benefits of XML formats, phases of implementation, and the transformative potential for pharmaceutical companies. TransPerfect Life Sciences...
Transitioning Clinical Trials Under the EU CTR
The transition from Clinical Trial Directive to Clinical Trial Regulation in Europe adds new requirements and complexities to the clinical development landscape. The required transition of all trials concluding January 1st, 2025 brings about several considerations to ensure...
Navigating the Regulatory Landscape for Expanded Access Programs
Preview: Discover the world of expanded access programs (EAPs) and the dynamic regulatory environment they operate in. In this blog, we delve into the significance of EAPs, the evolving global regulations governing them, and the vital role they play in providing timely treatment...
EU CTR: An Introduction to European Clinical Trial Transparency
Are you looking to stay ahead of the curve in the ever-evolving landscape of European clinical trials? We are thrilled to announce the availability of our newest on-demand webinar, in which we dive deep into the recent changes to the European Clinical Trial Regulation (EU CTR)...
EU CTR White Paper - Operational Considerations & Challenges
The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness...
Navigating the EU Clinical Trial Regulation Complexities - Current Challenges and Opportunities
As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. The first-year transition period has now ended, and from January 31, 2023, EU...
IMP Labeling: EU CTR Transition Considerations
The blog post explores the critical aspects of transitioning Investigational Medicinal Product (IMP) labeling from the EU Clinical Trial Directive (EU CTD) to the new EU Clinical Trial Regulation (EU CTR). ...
Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider
Assessing Readiness for EU Clinical Trials Regulation (CTR): Five Points to Consider...
Driving Digital Excellence: Delivering Seamless and Personalized Customer-Centric Experiences
The digital evolution in reaching and engaging with global communities, including sponsors, CROs, patients, and HCPs, has drastically shifted the way medical affairs teams connect with key stakeholders. As the industry pursues ways to improve a consumer and patient-centric...
Top 10 Biotechnology Company Captures and Disseminates Insights from a Key Advisory Board Meeting
The company enlisted the support of TransPerfect to provide a medical writer with expertise in the genetic disease to transcribe the meeting in full and produce an executive summary detailing the main takeaways and discussions....
Clinical Data Services Company Launches its Statistical Webinar Series
“Another great seminar in a long line of excellence. I can only say, keep it up!”...
Global Pharma Saves $1.1M with Regulatory Translation Solution
AI-powered workflows to help reduce costs and timelines while being scalable to the large volume of content required....
Content Automation to Meet MDR & IVDR Requirements
Marc Miller, President of TransPerfect's Medical Device Solutions chatted with experts from Takeda Pharmaceuticals & QServe to learn about MDR & IVDR labeling compliance while cutting risk, cost, & turnaround by using structured content, process automation, &...
