Services

Offerings include a wide array of options—from onsite training's of client employees to complete submission of client projects. Clients are able to choose the level of support they require from our "menu of services" to best accomplish their goals in the most cost-effective manner.

Electronic Publishing and Submission of Marketing Applications, Amendments and Supplements

  • Project Management from project start-up through submission

  • Establishing metadata, appropriate granularity, and basic document conventions

    • Management of Lifecycle submissions

    • Electronic Submission via the Electronic Submission’s Gateway (ESG)

    • Application conversion from paper to eCTD

Working in Office

Document Formatting and Publishing

  • Creation of MS Word Style Guides

  • MS Word documents formatting

  • Ensuring document aligns with styles and templates

  • PDF creation and manipulation to add navigation to comply with regulatory guidance

  • 100% Quality Check of all documents

Other Services

  • Regulatory Affairs Consulting

  • US Agent Services

  • Clinical Study Report Publishing

  • Management and Submission of IND Safety & Adverse Event Reports

  • Document and Publishing Training

Business Consultant

A Full Service Regulatory Operations Company

Cost effective, quality solutions for all of your regulatory document needs.

Address

PO Box 91594

Raleigh, NC 27675

Email

Phone

Contact Us

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