EXPERT CMC REGULATORY AFFAIRS CONSULTING
Regulatory Affairs and CMC Services
Whether you’re a start-up with a single pre-clinical asset or an established sponsor managing post-approval changes for your 20th, there are always decisions to be made. Having years of industry experience, GLOBAL’s strategic advisors will listen and collaborate with you to formulate the best regulatory, technical, and quality strategies to position you for success.
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 Regulatory Consulting
You don’t have unlimited time or resources. You need to get your product to market correctly, quickly, and on-budget. You might be asking yourself questions like, “How much data should I include with my pre-clinical IND?”, “How should I reply to that information request?”, and “We made some process changes, how do I know if I need a bridging study?”. The questions and challenges of launching a new product can feel endless.
At GLOBAL, we’ve seen it all and helped our clients through countless submissions. Count on us for your:
- Global regulatory strategy
- Regulatory submission approach
- Regulatory landscape navigation
- Regulatory positioning
- Orphan drug, rare disease, breakthrough therapy, and emergency use authorization designations
Technical Support
Our world-class scientists can guide you product from inception to bedside and through the many product and process development hurdles along the way. We apply our knowledge of health authority requirements, technical acumen, and industry best-practices to prepare strategies and technical documents that are fit for purpose, scientifically sound, and aligned with agency requirements.
- Tech transfer planning and execution
- Strategic review of development plans
- Master validation planning
- Product control strategies
- Product lifecycle support
- Risk mitigation approaches
- CDMO selection
Quality & Compliance Support
Your quality management system is a living thing that requires regular maintenance. At GLOBAL, we'll work with you to create and maintain your quality system in a way that maximizes the value that you deliver to your customers, while keeping you compliant with industry requirements.
- Phase-appropriate quality management system creation
- Change impact assessments
- On-site audit support
- Compliance gap remediation strategies
- Data verification
- Post-approval reporting guidance
Strategic Expertise that Accelerates Success
When it comes to CMC regulatory consulting, experience matters. At GLOBAL, our advisors bring decades of combined knowledge in regulatory affairs, technical development, and quality systems to every engagement. We don’t just answer questions—we anticipate challenges, navigate regulatory landscapes, and design strategies that keep your product on track for approval. Our team’s collaborative approach ensures your documentation is scientifically sound, compliant with health authority requirements, and ready to support every stage of your product’s lifecycle.