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Regxia Inc.
Expert Regulatory SolutionsProducts
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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Projects
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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Overview
Gap Analysis of Dossiers and Responses
Regxia’s extensive experience creating and adapting submissions for the FDA and Health Canada allows us to identify potential questions from regulatory agencies during assessment and, most importantly, pro-actively develop resolutions. Regxia is able to assess dossiers for strengths and weaknesses, regulatory authority acceptance and identify corrective measures before substantial investments have been made .
Support for Agency Meetings
On behalf of our customers, Regxia has arranged for timely meetings, prepared high-quality and effective briefing documents and provided advice on presentation content and format.
Literature Reviews to support SRTD or 505(b)(2) Applications
Regxia's team has experience conducting systematic literature reviews to support your SRTD or 505(b)(2) application.
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