We tailor our services to meet the unique needs of each client, providing flexible and scalable solutions. Our expertise ensures that your products comply with international regulations, streamline submissions processes, and achieve market success.
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.
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!
In just the device post-approval space, the EU MDR mandates various post-market documents for each device in your portfolio, including CEP/CER, PMCF Plan/PMCF Report, PMS Plan/PSUR or PMS Report, and SSCP, all requiring regular updates.
And, a typical biological product necessitates over 60 Module-3 Quality sections for just one BLA, and source docs for Module-2 Clinical section can be over 3,000 pages long!
Managing these schedules and deliverables across a large portfolio can be challenging without the right tools and processes. Effective project management can optimize work, accurately estimate resource needs, and reduce team stress and turnover.
GLOBAL’s project management service offerings include thefollowing:
Training new writers can be a challenge for even the most resourceful teams. At GLOBAL, we understand the unique hurdles faced by organizations of all sizes, from small teams with limited budgets to large teams overwhelmed by demanding workloads. Our customized training programs are designed to support your writers, providing them with the skills and knowledge they need to succeed, without overburdening your experienced staff. Whether you're building out your internal team or efficiently, GLOBAL is here to ensure your writers thrive.
GLOBAL's Training Offerings Include:
This course includes an overview and introduction to theclinical evaluation process. Complete with GLOBAL’s best practices and tips andtricks for success, this essentials course is perfect for getting novicewriters on your team up and running. This training course includes:
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:
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).
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
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.
This 10-hour, interactive course provides an introduction to the basics of CER writing, with an emphasis on the practical interpretation of regulations and guidelines.
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