CMC SERVICES THAT SIMPLIFY COMPLEX REGULATORY PATHWAYS
CMC Regulatory, Technical and Quality
Our world-class scientists and regulatory experts can guide your product from inception to bedside and through the many regulatory, technical, and quality and hurdles along the way. We apply our knowledge of health authority requirements, technical acumen, and industry best practices to prepare regulatory, technical, and quality system documents that are fit for purpose, scientifically sound, and aligned with agency requirements. Please see our most common services below and reach out to explore how we can best support your team!
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.
CMC Services by Experts Who Care
We apply our knowledge of health authority requirements, technical acumen, and industry best practices to prepare regulatory, technical, and quality system documents that are fit for purpose, scientifically sound, and aligned with agency requirements. Please see our most common services below and reach out to explore how we can best support your team!
Our CMC Services
Regulatory Affairs and CMC Services
- Regulatory strategy
- INDs and IMPDs
- BLA, NDA, MAA, 510k license applications
- Agency information requests, clinical holds, and complete response letters
- Agency meeting requests, briefing books, and interactions
- DSURs, annual reports
- Drug Master Files (DMFs)
- Post-approval supplements
- Change control assessments
- Due diligence and gap analyses
- Controlled correspondence
- Regulatory advocacy and policy
- Orphan Drug, Rare Disease, Breakthrough Therapy, and Emergency Use Authorization applications
Technical Services
• Tech transfer protocols
• Comparability study protocols
• Commercial product control strategies
• Process risk assessments
• Process validation/PPQ protocols, reports
• Analytical method development
reports
Quality Services
• SOPs, policies, and other GxP documentation
• Data verification
• Gap analysis and remediation
• Deviation investigations
• Compliance gap assessment
• CMO and supplier quality agreements