Streamline your Regulatory Process with Our Expert Writing Services

Alleviate the Regulatory Writing Burden

Our experienced in-house writers deliver precise, compliant, and high-quality regulatory documents. We offer a full suite of writing services to cover all your document needs.

Leverage our experienced writers who understand the intricacies of regulatory requirements across diverse topic areas and collaborate with cross-functional teams to support the development of clear and compliant clinical trial, regulatory, and GMP documents.

Medical Writing

We offer a suite of specialized writing solutions to support your regulatory submissions, documentation, and communication needs. Whether you're navigating the complexities of clinical trial protocols, preparing regulatory submissions, or crafting scientific narratives, we have the expertise to ensure your documents are precise, compliant, and impactful in moving your program forward.

Our medical writing team capabilities include:

Clinical trial documents
Regulatory interaction documents
Submission documents
Safety documents
Project management
Publishing
Support for both pharmaceuticals and medical devices

The GLOBAL Team Approach:

Agile support with creative problem solving skills to support client goals
Writers with unique skills sets offering full circle knowledge of nonclinical requirements and their impact to clinical development programs
Team approach offering continuity and consistency to our Sponsors across programs
High rate of repeat business due to excellence in performance
Flexible contracting arrangements to accommodate your project and budgetary needs

EU MDR Regulatory Writing

Navigating the complexities of new medical device regulations, particularly the European Medical Device Regulation (EU MDR), is a challenging endeavor for manufacturers. GLOBAL offers comprehensive regulatory writing services tailored to meet these stringent requirements, ensuring seamless compliance and quality submissions.

Clinical Evaluation: CEP, CER
Post-Market Surveillance: PMS Plan, PMS Report, PSUR
Post-Market Clinical Follow-up: PMCF Plan, PMCF Report
Patient and Provider Facing Documents: SSCP, IFU, PIL
Technical Documentation Compilation

In-Vitro Diagnostics

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We provide a wide range of medical and regulatory writing services for in vitro diagnostics (IVD) manufacturers, from EU MDR / IVDR regulatory writing to literature review, clinical study reports, and scientific articles.

IVDR Regulatory Writing

Performance Evaluation Documentation: PEP, PER
Patient/Healthcare Professional Facing Documentation
Post-Market Planning/Reporting Documentation
Data Processing
IVDR-Readiness Assessments
Regulatory Writing

CMC Regulatory, Technical, and Quality

CMC Regulatory, Technical, and Quality Services

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!

CMC Regulatory Services

Regulatory strategy
IND, and IMPD clinical trial applications
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
DEA Quota requests
Change control assessments
RLD and IIG excipient reviews
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
Phase-appropriate quality system creation
Data verification
Gap analysis and remediation
Deviation investigations
Compliance gap assessment
Pre-approval “mock” inspections and readiness
CMO and supplier quality agreements