Regulatory Submission and Publishing Services
The PPD™ clinical research business of Thermo Fisher Scientific helps you overcome the challenges that continually arise in an environment of ever-evolving global regulations, increased globalization and redefined stakeholders. With innovative solutions and extensive experience, our submission publishing service experts are available to partner with you to create the optimum solution for any clinical document submission and publishing need.
Comprehensive services customized to meet your needs
Submission component preparation
- Scanning services and legacy document conversion
- Document and report publishing
- Structured product labeling conversion services
- Clinical Data Interchange Standards Consortium (CDISC) and U.S. Food and Drug Administration (FDA) submission data conversion services
Global submission publishing
- Paper submission publishing
- Electronic common technical document (eCTD) submission planning and tracking
- Electronic submission publishing, including eCTD and non-eCTD electronic submission and hybrid formats
- Conversion of paper/legacy format to eCTD format applications
- Staff augmentation
Consulting
- Regional regulatory consultation
- Defining eCTD granularity
- Submission readiness assessment, including eCTD readiness review and gap analysis
Training and education
- Introduction to electronic submissions and authoring for eCTD submissions
- Submission and document lifecycle processes and concepts
- Considerations for report and case report form publishing
- Publishing clinical study reports for paper and electronic submissions
Efficient, effective multicountry filing
Specializing in global development, our submission publishing services group can help plan, manage and prepare for global, multicountry simultaneous or sequential filings and meet all product development milestones. We are experienced in developing and submitting regulatory applications globally with specialized expertise in applications types such as common technical documents (CTD) and eCTD in specific regional formats:
- FDA: new drug application (NDA) and investigational new drug (IND)
- European Medicines Agency (EMA): marketing authorization application (MAA) and clinical trial authorization (CTA)
- Canadian Health Authority: new drug submission (NDS) and CTA
Advanced clinical submission and publishing technologies
Our regulatory experts employ proven software solutions to deliver compliant, timely submission component documents and valid electronic submissions.
Secure electronic submissions and web-based document review
Using cutting-edge technologies, we and our clients are able to seamlessly share and transfer files in a secure manner, via secured Web portal or eDMS connections. We can provide you a Web-based eCTD viewer for internal access to the submission during the assembly process.
In addition, FDA submissions sent by us can leverage the FDA Electronic Submission Gateway to expedite the delivery and validation of submissions.
