Regulatory
Publishing
A typical regulatory submission contains thousands of pages of data and documentation that need to be compiled, formatted, linked and indexed, and meticulously reviewed for accuracy to properly meet the regulatory agency’s current standards for approval.
At Accorto Regulatory Solutions, our team specializes in managing differences in eCTD submission criteria per region (globally), supporting your application throughout the entire documentation lifecycle, and meeting your organization’s goals on expediting your release to market.
Our subject matter experts are ready to tackle your IND, NDA, ANDA, BLA, PMTA or Masterfile submissions. Speak with an expert and learn how Accorto can help you reach your business goals today.
Regulatory
Publishing
A typical regulatory submission contains thousands of pages of data and documentation that need to be compiled, formatted, linked and indexed, and meticulously reviewed for accuracy to properly meet the regulatory agency’s current standards for approval.
At Accorto Regulatory Solutions, our team specializes in managing differences in eCTD submission criteria per region (globally), supporting your application throughout the entire documentation lifecycle, and meeting your organization’s goals on expediting your release to market.
Our subject matter experts are ready to tackle your IND, NDA, ANDA, BLA, PMTA or Masterfile submissions. Speak with an expert and learn how Accorto can help you reach your business goals today.
Consulting
Submission Component Preparation
Electronic Submission Services
Consulting
Our team provides all resources needed for audits and inspections. This includes audits for current Good Manufacturing Practices (cGMP), Good Clinical Practices (CLP), International Organization for Standardization (ISO), Regulatory Gap Analyses, Risk Assessments, Pre-Approval, Supplier, and more.
Submission Component Preparation
Our team of experts provide consulting services in Total Quality Management (TQM), Quality Management Systems (QMS), CAPA Quality Systems, Good Laboratory Practice (GLP), current Good Manufacturing Practices (cGMP) and more.
Electronic Submission Services
eCTD, or electronic common technical document filing, is the standard submission format for FDA regulatory application submissions. Leverage our publishing experts to comply with FDA’s standard eCTD submission format in a new application or convert an existing paper application to the required electronic format.
- Electronic common technical document (eCTD) submission planning and tracking
- Formatting to ensure documents meet FDA eCTD compliance standards
- Electronic submission publishing, including eCTD and non-eCTD electronic submission and hybrid formats
- Conversion of paper submission formats to eCTD format applications
- Publishing clinical study reports for electronic submissions
- Cross-document hyperlinking
- Internal review of all documents for accuracy along with sponsor review
- Application Submission
Consulting
- Regional regulatory consultation
- Submission assessment, including eCTD readiness review and gap analysis
Submission Component Preparation
- Scanning services and paper document conversion
- Document and report publishing
- Summaries
- Cover Letters
- Reviewer’s Guide
- Table of Contents
- Additional documents as needed
- Clinical Data Interchange Standards Consortium (CDISC) and U.S. Food and Drug Administration (FDA) submission data conversion services
- Compilation and formatting of all documentation
Electronic Submission
Services
eCTD, or electronic common technical document filing, is the standard submission format for FDA regulatory application submissions. Leverage our publishing experts to comply with FDA’s standard eCTD submission format in a new application or convert an existing paper application to the required electronic format.
- Electronic common technical document (eCTD) submission planning and tracking
- Formatting to ensure documents meet FDA eCTD compliance standards
- Electronic submission publishing, including eCTD and non-eCTD electronic submission and hybrid formats
- Conversion of paper submission formats to eCTD format applications
- Publishing clinical study reports for electronic submissions
- Cross-document hyperlinking
- Internal review of all documents for accuracy along with sponsor review
- Application Submission
