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Regxia Inc.
Expert Regulatory SolutionsProducts
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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Projects
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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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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