regulatory strategy consulting

Regulatory Strategy Consulting Success Stories

Explore how GLOBAL develops solutions-oriented and project-specific strategies to help ourregulatory strategy consulting clients reach their goals through the below case studies.

Global's Medical Writing Capabilities

Medical Writing Case Study

Partnering for Efficient Medical Writing Solutions

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Global's Medical Device Capabilities

EU MDR Case Study

Long-Term Partnership with Large Multinational Corporation for EU MDR Remediation of an Entire Portfolio

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Global's EU MDR Capabilities

EU MDR Case Study

GLOBAL made sure the client's investigational new drug application was submitted on time and followed all FDA requirements.

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Global's Medical Writing Capabilities

Medical Writing aCSR Case Study

GLOBAL helped a mid-sized biopharmaceutical company develop a throughough aCSR, aiding with writing support, review cycles, and project management.

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Global's Medical Device Capabilites

EU MDR Case Study

GLOBAL developed a strategy which included templates and documents that followed EU MDR compliance and requirements.

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Global's Regulatory CMC Capabilities

CMC Case Study

Consulting and Authoring an Investigational New Drug Application

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Global's Regulatory CMC Capabilities

Regulatory Operations Case Study

Sequence/Serial Numbering for an Initial IND

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Global's Medical Device Capabilities

EU MDR Case Study

Periodic Safety Update Report (PSUR) Vigilance Data Reporting

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Global's Regulatory CMS Capabilities

CMC Case Study

Navigating the Complexities of a Microbiome Product Filing

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Global's Medical Writing Capabilities

Regulatory Operations Case Study

A new client requested publishing for an IND with a tight deadline

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Global's IVD Capabilities

EU IVDR Case Study

Mid-Size Genetic Testing Firm seeking support implementing the new EU IVDR standards

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Global's Medical Device Capabilities

PMA Case Study

Clinical Investigational Reports for Medical Devices: Supporting Compliance with a Cross-Functional Team

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GLOBAL provides trusted regulatory consulting , writing, and technology solutions to help manufacturers bring products to patients at a life saving pace. We’ll be with you every step of the way.

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