GLOBAL
Global Regulatory Writing and Consulting provides tailored regulatory consulting, writing services, and strategic expertise to medtech and biopharma innovators. They support clients from product development through market approval, leveraging proprietary AI technology and a collaborative approach to navigate complex regulatory landscapes efficiently and effectively. The company also emphasizes the importance of expert, flexible, and innovative approaches in regulatory submissions, including eCTD publishing, IND applications, and adverse event reporting, with a focus on compliance, accuracy, and efficiency.
Industries
Nr. of Employees
medium (51-250)
GLOBAL
Tukwila, Washington, United States, North America
Products
AI-powered regulatory authoring platform
A cloud-capable authoring platform that uses AI/ML to assist regulatory document drafting and structured data extraction with side-by-side source viewing, table-aware extraction and mapping, predictive data retrieval, automated audit trails, and data verification workflows to support DV and traceability.
AI-based complaint and adverse event coding tool
An application that automates initial categorization of complaints and adverse events using IMDRF terminology and hierarchical classification models, producing suggested codes for human review and exportable audit trails to support PSURs and regulatory reporting.
AI-powered regulatory authoring platform
A cloud-capable authoring platform that uses AI/ML to assist regulatory document drafting and structured data extraction with side-by-side source viewing, table-aware extraction and mapping, predictive data retrieval, automated audit trails, and data verification workflows to support DV and traceability.
AI-based complaint and adverse event coding tool
An application that automates initial categorization of complaints and adverse events using IMDRF terminology and hierarchical classification models, producing suggested codes for human review and exportable audit trails to support PSURs and regulatory reporting.
Services
Authoring and editing regulatory documents across product types and development stages, including clinical study reports, protocols, investigator brochures, CMC/module content, clinical evaluation reports, and periodic safety reports.
Pathway assessment, gap analysis, regulatory roadmaps, and strategic planning for drug and device development programs, plus preparation for agency interactions.
End-to-end support for U.S. regulatory filings including device submissions (510(k), PMA, De Novo) and IND dossier assembly, encompassing technical authoring, CMC summaries, nonclinical/clinical documentation and pre-submission preparation.
Technical compilation, formatting, validation and packaging of electronic submissions for regulatory gateways, including pre-submission validation, SEND considerations, and eCopy preparation.
Domain-experienced project management for submission lifecycles, integrating regulatory, clinical, and manufacturing inputs with timeline control, quality checks, and stakeholder coordination.
Courses and workshops to upskill regulatory writing teams on document preparation, clinical evaluation reporting, publishing best practices, and submission strategy.
Authoring and editing regulatory documents across product types and development stages, including clinical study reports, protocols, investigator brochures, CMC/module content, clinical evaluation reports, and periodic safety reports.
Pathway assessment, gap analysis, regulatory roadmaps, and strategic planning for drug and device development programs, plus preparation for agency interactions.
End-to-end support for U.S. regulatory filings including device submissions (510(k), PMA, De Novo) and IND dossier assembly, encompassing technical authoring, CMC summaries, nonclinical/clinical documentation and pre-submission preparation.
Technical compilation, formatting, validation and packaging of electronic submissions for regulatory gateways, including pre-submission validation, SEND considerations, and eCopy preparation.
Domain-experienced project management for submission lifecycles, integrating regulatory, clinical, and manufacturing inputs with timeline control, quality checks, and stakeholder coordination.
Courses and workshops to upskill regulatory writing teams on document preparation, clinical evaluation reporting, publishing best practices, and submission strategy.
Expertise Areas
- Regulatory writing and medical/scientific authoring
- U.S. medical device submissions and device regulatory strategy
- IND preparation and early clinical regulatory strategy
- CMC and quality documentation for biologics and small molecules
Key Technologies
- AI/ML for document authoring and data extraction
- Table-aware data extraction and source-to-target mapping
- Automated audit trails and data traceability
- eCTD/electronic submission formatting and validation tools
News & Updates
How Florence Nightingale's principles helped guide COVID-19 response efforts, emphasizing the importance of statistical analysis, preparedness, healthcare worker protection, community engagement, and evidence-based decision making.
Overview of FDA initiatives to streamline the review process for Type II DMFs under GDUFA, including timelines, guidance, and new electronic forms.
Strategies for effective resource planning, building flexible teams, leveraging technology, investing in training, and balancing quality with efficiency in regulatory writing.
Guidance on using templates, verifying guidance updates, and building strong foundations for technical writing.
Key considerations for selecting a medical writer, including background, skills, soft skills, project management, and how to evaluate candidates.
Core requirements for IND submission, importance of pre-IND meetings, and how to prepare for a successful IND.
How Florence Nightingale's principles helped guide COVID-19 response efforts, emphasizing the importance of statistical analysis, preparedness, healthcare worker protection, community engagement, and evidence-based decision making.
Overview of FDA initiatives to streamline the review process for Type II DMFs under GDUFA, including timelines, guidance, and new electronic forms.
Strategies for effective resource planning, building flexible teams, leveraging technology, investing in training, and balancing quality with efficiency in regulatory writing.
Guidance on using templates, verifying guidance updates, and building strong foundations for technical writing.
Key considerations for selecting a medical writer, including background, skills, soft skills, project management, and how to evaluate candidates.
Core requirements for IND submission, importance of pre-IND meetings, and how to prepare for a successful IND.