Global’s Medical Writing Capabilities
Project Management including schedule creation and full-service project management of EU MDR deliverables
Training including our regulatory writing internship program, CER essentials course, and custom training programs
Regulatory & Technical Consulting including CER strategy, PMCF strategy, SOP review, and template review
Medical & Regulatory Writing including CEP/CERs, PMCF & PMS Plans/Reports, PSURs, SSCPs, and Literature Reviews
About the Client
Client T, a small start-up, has developed several novel Class IIa technologies in a niche market. Like many new companies, Client T faced the challenge of meeting regulatory requirements across multiple geographies and lacked the in-house resources to ensure compliance with EU MDR. With a technical file review looming, Client T required a full remediation of a suite of documents within a tight 5-week timeline. Another CRO proposed a bid of nearly $500,000, surpassing Client T’s financial constraints. GLOBAL’s bid to complete the project was around $100,000.
About the Project
Client T needed 6 documents to be remediated and prepared within 5 weeks (CEP, CER, PMCF Plan, PMCF Report, PMS Plan, and PSUR). The templates had gone through some internal updates but were not fully MDR-compliant. GLOBAL’s consultants addressed the compliance issues in the templates and improved the formatting and organization to ensure a smooth Notified Body review process. After the template updates were complete, GLOBAL executed a literature review, state-of-the-art update, vigilance assessment, non-clinical data compilation, and data analysis to demonstrate conformity to the GSPRs. The route to conformity included a complex equivalence argument for which GLOBAL provided strategic consulting.
Global Solutions
GLOBAL executed the project using the company's values.
Outcome
- GLOBAL provided 6 total deliverables, while improving and providing updated templates, all within the proposed timeline.
- GLOBAL worked with Client T’s financial constraints to ensure they received the best deal possible.
- GLOBAL completed drafts of all deliverables within 5 weeks of the project kick-off.
- Client T received top-quality deliverables in the timeline required and within their budget.
Conclusions
Client T was immensely satisfied with the work GLOBAL executed. They were able to meet their internal deadlines and enter into their technical review with full confidence in the thoroughness and the overall quality of our work.