Verna Scientific

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Verna Scientific
Verna Scientific

Solutions > Regulatory Compliance

Verna provides Regulatory Compliance, Electronic Submission and Process Automation services for Pharmaceutical and Biotech Companies.

The Regulatory Affairs Team helps clients to prepare and review submissions and works to facilitate submission approval by national and international regulatory authorities.

  • Consultation
  • Regulatory Gap Analysis
  • Preparation of electronic submissions in compliance with FDA and ICH Guidelines
  • Regulatory document and submission management (IND, NDA, sNDA, ANDA, BLA, CTD, eCTD, AE Reporting)

Verna provides sponsors with technical guidance and regulatory expertise required to fully support the preparation of an electronic regulatory submission. Our expertise and familiarity with industry publishing technologies provides clients with the knowledge and support they need to select the best tool for their organization. Our publishing specialists are skilled at using a variety of industry standard systems. Verna provides:

  • PDF publishing for electronic regulatory submissions
  • Case Report Tabulation (CRT) development
  • SAS Data Definition Tables
  • Document conversion (Electronic and Paper)
  • CRF scanning and indexing
  • Patient Profiles creation
  • Submission QA services  

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