© 2019 Aroga Biosciences

12526 High Bluff Drive, Suite 235 San Diego, CA 92130

858-925-6145 | info@arogabio.com

OUR SERVICES

We provide a broad range of services within multiple therapeutic areas.

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

  • Clinical Study Reports

  • Clinical CTD summary documents for marketing applications (NDAs and BLAs)

  • Protocols and protocol amendements

  • Investigator’s brochures

  • INDs

  • Regulatory responses

  • Briefing packages

  • Pediatric study plans/Pediatric Investigational Plans

  • Orphan drug application/European Orphan Medicinal Product Designation (OMPD)

  • White papers

  • PSURs/DSURs

  • Risk Management Plans

  • Company Core Safety Information

  • Development Core Safety Information

  • Manuscripts/abstracts

  • Publication planning

  • Submission/Project Management

  • Dossier Strategy/Submission Planning

  • Clinical Development Plans

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

  • Formatting

  • Assembly of CSR appendices

  • Bookmarking/hyperlinking of documents 

 

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