LET GLOBAL SUPPORT THE REGULATORY SUBMISSION PROCESS
Submission Management
Managing a regulatory submission requires an understanding of the entire regulatory submission process from start to finish. Successful submission management requires experience navigating interdependent modules, coordinating authoring timelines, and making informed decisions when source documents aren’t final. Done well, it position your product for approval.
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.
Submission Management Backed by Experience
Not everyone can or should manage a regulatory submission. Having context to the work is critical; understanding the inter-relationships between module sections, knowing the authoring cadence, knowing how to proceed without finalized source docs, and knowing where to stand firm to avoid risks, are all attributes of a strong submission manager that can only come after years of successful submission writing and industry experience.
At GLOBAL, we know how to provide the highest level of submission management service because we combine our foundational submission knowledge with our project management skills and your unique product’s and company’s needs. We can draft sections. We can draft source documents. We can and do work with Sponsor CMOs to draft sections. We can get your submission across the line, efficiently, on-time, and at the highest quality.
Contact us to discuss your next submission!
Why Choose GLOBAL for Your Regulatory Submission Process
Proven Expertise
Our publishing team has decades of hand-on experience across global markets.
Holistic Oversight
We understand the interdependencies of the regulatory submission process and ensure each
detail aligns seamlessly.
Attention to Detail
Our team carefully reviews every file before submission.