Strategic Regulatory Writing & Consulting Services for Every Development Stage
Regulatory Writing
Clinical/Non-Clinical
Develop a data-driven approach to regulatory documentation that ensures both clinical decision-makers and regulatory authorities can access the most relevant information.
Medical Devices
We provide comprehensive EU MDR regulatory writing services for medical device manufacturers, including clinical evaluations, post-market surveillance and clinical follow-up documentation, patient and provider materials, and technical file compilation to ensure compliance and high-quality submissions.
CMC Regulatory, Technical and Quality
We provide expert CMC regulatory, technical, and quality services, helping life science companies navigate global health authority requirements with strategies, documentation, and compliance support from early development through post-approval.
In-Vitro Diagnostics
We provide comprehensive medical and regulatory writing services for IVD manufacturers, including IVDR documentation, clinical and scientific writing, literature reviews, post-market reporting, and readiness assessments to support compliance and product success.
Consulting Services
Regulatory Affairs and CMC Services
Get expert support for CMC regulatory consulting, technical guidance, and quality systems that ensure your product’s success from development through approval.
EU MDR Consulting Services
Navigate European Medical Device Regulation requirements with strategic guidance, compliance tools, and proven expertise.
Clinical/Non-clinical Strategy
We partner with your team to deliver data-driven regulatory and clinical writing services, including authoring, editing, QC, publishing, and project management, ensuring clear, compliant, and accessible documentation for regulators, clinicians, and patients alike.
Regulatory Writing
Training & Education
We provide customized training programs and mentorship to build internal expertise, equipping your team to confidently produce compliant, high-quality regulatory documents.
Project Management
GLOBAL’s project managers optimize schedules, resources, and deliverables to reduce risk, improve efficiency, and keep complex submission portfolios on track.
Submission Management
We combine regulatory expertise with hands-on project experience to oversee submissions from start to finish, ensuring accuracy, timeliness, and quality.
eCTD Publishing
Our dedicated publishing team leverages deep technical knowledge and industry-leading tools to efficiently prepare, validate, and deliver compliant eCTD submissions.
