GLOBAL Regulatory Writing & Consulting
Empowering Your Regulatory Success with Unmatched Writing Services

GLOBAL Regulatory Writing & Consulting is a leading regulatory writing and consulting firm specializing in drug and device consulting, regulatory submission support, and strategic writing. Its unparalleled expertise lies in regulatory writing, where precision and clarity are critical in navigating intricate regulations and guidelines.

“We adopt a tailored and refined methodology in our endeavors and deeply value the distinctiveness of each product, ensuring it receives meticulous and personalized care,” says Emily Stephens, CEO of GLOBAL Regulatory Writing & Consulting.

The services encompass comprehensive clinical and nonclinical authoring for pharmaceutical applications, diligent management of chemistry, manufacturing, and controls (CMC) activities for investigational and commercial purposes, and meticulous handling of regulatory submissions for medical devices. It emphasizes adherence to the specific requirements of the EU Medical Device Regulation (MDR). By combining the expertise of professionals with strategic guidance, GLOBAL consistently produces exceptional, reader-centric documents of the utmost quality.

Clients gain access to a highly-skilled, multidisciplinary writing staff possessing a wealth of experience in rapidly assimilating intricate projects and collaborating seamlessly to deliver outputs of optimal quality.

This experienced workforce enables GLOBAL to have swift and flexible operations, efficiently addressing each client’s unique requirements. Over the past seven years, it has established a legacy of success by implementing tailored solutions prioritizing client needs, resulting in numerous approvals from global regulatory authorities. Whether early-phase development, technical transfer, commercial filings for various products, or customized software solutions, GLOBAL’s competent team possesses the expertise to meet and exceed client expectations.

The prevailing economic uncertainty has impacted both the broader markets and GLOBAL’s clients. It is committed to supporting them by offering flexible contracting and service options tailored to their needs.

These options include embedded FTEs, project-based contracts, and various short-term and long-term arrangements for portfolios of all sizes. GLOBAL provides rigorous project and portfolio management, consulting services, and training programs to enhance the capabilities of internal teams. Focused on developing cost-efficient solutions, GLOBAL remains dedicated to helping clients navigate the challenging economic landscape.

One of GLOBAL’s key strengths lies in its adeptness at engaging with clients and fostering collaborative partnerships to develop effective solutions. Many clients approach the company with a limited understanding of the precise services they require. Leveraging its expertise, GLOBAL excels in working collaboratively to articulate cost-effective support strategies that expedite success.

All these competencies were showcased when a prominent manufacturer faced challenges complying with the medical device regulation (MDR). Identified issues included delayed updates, unclear remediation plans, and limited internal resources. GLOBAL partnered with the client, providing writing support and project management. A dedicated project manager facilitated a comprehensive three-year schedule, ensuring coordination and monitoring progress. Long-term plans and tracking tools were implemented for sustained compliance and process improvements. This successful partnership highlighted GLOBAL's proficiency in strategic guidance, project management, and writing support for regulatory compliance.

GLOBAL's Chemistry, Manufacturing, and Controls (CMC) team, comprising engineers, scientists, technical writers, and regulatory experts, excels at integrating into all stages of product development. It recently helped a client file a successful BLA for a groundbreaking microbiome product, recognized with breakthrough therapy and orphan drug designations. GLOBAL’s expertise in project management, technical writing, and regulatory affairs was crucial.

The company's competitive edge lies in its exceptional workforce, which is highly skilled, motivated, and predominantly based in the U.S. GLOBAL focuses on attracting and retaining top talent, resulting in exemplary client outcomes. It adapts quickly to complex issues by establishing flexible contracts and implementing cost-effective solutions aligned with health authority expectations. This approach has contributed to GLOBAL's history of success and its eagerness to collaborate on future projects.