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

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)

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

CMC

Aroga's document types include (but are not limited to):

  • Module 2 and Module 3 CMC summaries
  • Technical Reports
  • Investigational Medicinal Product Dossier

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

Publications / Manuscripts

Aroga's document types include (but are not limited to):

  • Manuscripts
  • Abstracts
  • Posters
  • White Papers
  • Blog Articles

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

Formatting

Aroga ensures the cohesiveness of deliverables by specializing in the following services:

  • Formatting
  • Assembly of CSR appendices
  • Bookmarking/hyperlinking of documents

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