SIMPLIFY YOUR PATH TO COMPLIANT SUBMISSIONS WITH ECTD PUBLISHING SERVICES
eCTD Publishing
GLOBAL’s dedicated eCTD publishing team has decades of combined industry experience in Submission Project Management and Submission Publishing execution.
Our team has in-depth technical knowledge of all eCTD guidance and requirements, which combined with our attention to detail, will ensure submission compliance at every step of the process.
We use Certara’s GlobalSubmit™ eCTD submissions management software. We work with these exceptional tools to efficiently publish, validate, and review your eCTD submissions to support your team’s race to meet deadlines. Contact us for more information or to set up a quick initial assessment.
Intro to CERs Training Course
This course includes an overview and introduction to the clinical evaluation process. Complete with GLOBAL’s best practices and tips and tricks for success, this essentials course is perfect for getting novice writers on your team up and running. This training course includes:
• Live, online training sessions
discussing CER components and key strategies for success
• Access to recorded training sessions for reference
EU MDR Professional
Mentorship Program
Our professional mentoring program follows GLOBAL’s unique internship structure, customized for your team’s workflows, procedures, and device portfolio. Key aspects of the program include:
• Live, online training sessions with recordings and slide decks
• Practice assignments with answer keys
• Personalized feedback and guidance on the EU MDR documents in your team's pipeline
CER Bootcamp
The CER Bootcamp Course is an intensive training program designed to provide a thorough introduction to the clinical evaluation process. Tailored for novice writers, this course leverages
GLOBAL’s best practices, tips, and tricks to get your team up and running efficiently. Combining live, interactive sessions with comprehensive resources, the bootcamp ensures participants gain
the essential skills needed to produce high-quality Clinical Evaluation Reports CERs).
Train the Trainer Masterclass
The Train the Trainer Masterclass is aspecialized program designed to equip trainers with the skills and knowledge needed to effectively teach and mentor teams in the key deliverables required for EU MDR compliance (CER/CEPs, PMCF Plans/Report, PMCF Plans/Reports, PMSPlan/PSURS and PMS Reports).
Leveraging GLOBAL’s proven methodologies and best practices, this masterclass ensures that trainers are fully prepared to deliver high-quality, impactful training sessions and provide ongoing mentorship.
Custom Training Solutions
At GLOBAL, we understand that each organization has unique needs and challenges. That's why we offer custom training solutions designed to empower your team with the specific knowledge and skills required to write effective and compliant Clinical Evaluation Reports (CERs) and other EU MDR deliverables. Our bespoke training programs are crafted to align with your workflows, procedures, and device portfolio, ensuring immediate and practical application.
Work with GLOBAL for eCTD Publishing
GLOBAL’s dedicated eCTD publishing team has decades of combined industry
experience in Submission Project Management and Submission Publishing
execution.
Our team has in-depth technical knowledge of all eCTD guidance and requirements, which combined with our attention to detail, will ensure submission compliance at every step of the process. We use Certara’s GlobalSubmitTM eCTD submissions management software. We work with these exceptional tools to efficiently publish, validate, and review your eCTD submissions to support your team’s race to meet deadlines. Contact us for more information or to set up a quick initial assessment.
Why Partner with GLOBAL for eCTD Publishing?
Proven Expertise
Our publishing team has decades of hand-on experience across global markets.
Attention to Detail
Our team carefully reviews every file before submission.
Efficient Processes
Using advanced tools like Certara’s GlobalSummitTM enables us to streamline workflows to meet deadlines.