Whatever the challenge, we’ll ensure you meet your goals.
We provide the same outstanding quality of service across all electronic submissions, be it an IND submission, a biologics license application (BLA), conversion to eCTD format or simply the maintenance of an existing application.
We are your international partner.
Our global presence and international network of publishing experts means we’re perfectly placed to meet your needs in the US, Canada, Europe and beyond.
- eCTD submission outsourcing
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eCTD lifecycle management
We provide continued support for all future sequences of your application.
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ESG for FDA & Health Canada
We securely transmit to FDA or Health Canada using the authorized submission portal.
- Conversion of DMFs to eCTD
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Regulatory writing and review
Our medical writers and MDs can author your regulatory documentation.
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Regulatory affairs & operations
We provide regulatory project management and operations support as a matter of course.
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Staff augmentation
If you are short-handed we can provide additional regulatory support at most levels. We supply ad-hoc staff
members who are fully trained and ready to increase your deliverables. They can work with you ‘on-site’ or
remotely. - Regulatory strategy consulting
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Document level publishing
We prepare documents for publishing by optimizing templates, hyperlinking, bookmarking, formatting and
converting files to the necessary standards. - Document & submission QC
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Labeling, advertising & promotional materials
We provide SPL services, drug registration and listings, and 2253 submissions.
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Legacy paper management and conversion to eCTD
We deliver legacy paper submission publishing, NeeS and conversions to eCTD, including scanning services,
record management, site closures and M&A document transfers. - Business process analysis, consulting and optimization
- EU submissions
- Outstanding software