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Module 3 Solutions
↗Nashua, New Hampshire, USA
Module 3 Solutions is a specialized consulting and technology firm focused on the pharmaceutical industry, specifically in the domain of regulatory submissions. The company develops software tools and provides expertise to help pharmaceutical developers and regulatory professionals comply with FDA requirements for Chemistry, Manufacturing, and Controls (CMC) data, particularly within the context of the ICH eCTD Module 3.
The firm is deeply involved in the development of structured data standards, including the implementation of HL7 FHIR standards for PQ/CMC (Pharmaceutical Quality/CMC) submissions. Their flagship offerings include tools like 'Compose' that streamline the creation of FHIR XML files for regulatory filings, aiming to improve data quality, consistency, and compliance with evolving FDA standards.
CLASSIFICATION
Company Type:Digital Health
Therapeutic Areas:-
Industry:Pharmaceuticals
Sub-Industry:Regulatory Technology (RegTech) / Consulting
SIZE & FINANCIALS
Employees:1-50
Ownership:private
Status:operating
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CORPORATE STRUCTURE
Key Partnerships:US FDA (funded initiative for PQ/CMC), HL7 International (FHIR standard development)
COMPETITION
Position:Niche Player
LEADERSHIP
Key Executives:
Catherine Hosage Norman - President
LINKS
Website:module3solutions.com
Disclaimer: IntuitionLabs.ai is not affiliated with, endorsed by, or associated with Module 3 Solutions. The information on this page was compiled using AI from publicly available sources and may be incomplete, outdated, or contain errors. We are committed to correcting inaccuracies promptly upon notice. For official information, please visit the company's website directly.