REGULATORY STRATEGY & DOCUMENTATION FOR NEW DRUG APPLICATIONS
Clinical/Non-clinical Strategy
GLOBAL will collaborate with your team and subject matter experts to create a data-driven messaging strategy for all your documents. This approach ensures that both clinical decision makers and regulatory approvers can quickly access the most relevant product information. Our services include: content authoring, technical editing & formatting, QC review, document publishing, and project management.
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.
Regulatory Documents
- Investigational Applications
- Investigational New Drug Applications & Clinical Trial Applications
- Applicable CTD Summary Modules
- Briefing Books and Meeting Request Letters
- Pediatric Investigation Plans & Pediatric Study Plans
- Risk Management Plans
- Marketing Applications
- New Drug Applications, BLA, & Abbreviated NDA
- Applicable CTD Summary Modules
- Other Health Authority Communications
- Orphan Drug Designation requests
- Breakthrough Therapy Designation request
- Safety Management and Pharmacovigilance Documents / Aggregate Safety Reporting
- 120-Day Safety Update Reports
- Development Safety Update Reports
- Periodic Safety Update Reports
- Periodic Benefit-Risk Evaluation Reports
- Patient Safety Narratives
Non-Clinical Documents
- Project Management
- CTD Module 2
- CTD Module 4
- Regulatory Interactions - briefing, summaries, primary author, support team, and comprehensive quality reviews
Clinical & Non-Clinical Expertise for Confident Submissions
Navigating the complexities of clinical and non-clinical regulatory strategy, including the rigorous requirements of new drug applications, requires precision, foresight, and an understanding of how every document supports your overall approval pathway. At GLOBAL, we bring decades of experience guiding life science innovators through the stringent demands of regulatory authorities. From planning and authoring to review and publishing, we align your documentation with a clear, data-driven narrative, ensuring consistency, compliance, and impact across your submission package. Whether you’re preparing for new drug applications or advancing medical devices, our team delivers the expertise and collaboration needed to move you forward with confidence.