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Our Services
The Aroga team brings expertise from a broad range of therapeutic areas and document types.
Clinical
Regulatory
Safety
CMC
Non-Clinical
Publications / Manuscripts
Document Quality Control
Formatting
Dossier Strategy / Submission Planning
Clinical
Publications / Manuscripts
Regulatory
Document Quality Control
Safety
Formatting
CMC
Dossier Strategy / Submission Planning
Non-Clinical
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Clinical
Aroga's document types include (but are not limited to):
Clinical Study Reports
Protocols and Protocol Amendments
Investigator's Brochures
Clinical CTD summary documents for marketing applications (eg, NDAs and BLAs)
Clinical Development Plans
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Regulatory
Aroga's document types include (but are not limited to):
Clinical CTD summary documents for marketing applications (eg, NDAs and BLAs)
INDs
Regulatory Responses
Briefing Packages
Pediatric Study Plans/Pediatric Investigational Plans
Orphan drug applications/European Orphan Medicinal Product Designation (OMPD)
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Safety
Aroga's document types include (but are not limited to):
DSURs
IND Annual Reports
120-day Safety Update
PSURs
Risk Management Plans
Company Core Safety Information
Development Core Safety Information
Safety Signal Evaluation Reports
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CMC
Aroga's document types include (but are not limited to):
Module 2 and Module 3 CMC summaries
Technical Reports
Investigational Medicinal Product Dossier
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Non-Clinical
Aroga's document types include (but are not limited to):
Nonclinical Overview
Nonclinical Written and Tabulated Summaries
Investigator's Brochure
Nonclinical Study Reports
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Publications / Manuscripts
Aroga's document types include (but are not limited to):
Manuscripts
Abstracts
Posters
White Papers
Blog Articles
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Document Quality Control
Aroga ensures quality deliverables by providing quality control services:
Review against statistical data (tables and listings etc.)
Regulatory publishing readiness
Consistency in messaging, cohesiveness, grammar, and style guidelines
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Formatting
Aroga ensures the cohesiveness of deliverables by specializing in the following services:
Formatting
Assembly of CSR appendices
Bookmarking/hyperlinking of documents
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Dossier Strategy / Submission Planning
Aroga specializes in the following services:
Submission/Project Management
Dossier Strategy/Submission Planning
Standard Operating Procedures and Work Instructions
Strategic Consulting
