Regulatory Submission & Publishing Services
The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion, and regulatory study to develop. Full or partial outsourcing to a proven electronic common technical document (eCTD) partner is often the most cost effective solution, and one that gives your organization the flexibility to allocate resources to other projects.
Synchrogenix offers the following Regulatory Services:
- Regulatory submission and publishing services for investigational, pre-marketing, and marketing applications
- Subsequent lifecycle maintenance submissions (amendments, supplements, and reports)
- Drug Master File (DMF) submissions
- Paper to electronic format conversions
- U.S. Agent
The depth of our experience and knowledge acquired from our work with the US FDA, ICH, HL7 and industry groups is made available to our clients.
Our dedicated Regulatory Services publishing teams:
- Guide your organization through compilation of an original submission
- Perform submission maintenance
- Scale up to meet changing requirements and timelines
- Provide best practices training
- Offer extended working hours due to regional office locations on U.S. East and West coasts