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eCTD
- Software Selection & Implementation
- eSubmission ready processing
- Publishing
- Validation
- FDA Submission
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SPL / XML
- Software Selection & Implementation
- Content of Labeling
- Drug Samples (ACA 6004)
- Drug Listings
- Establishment Registration
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Providing our clients with options to fit their individual needs including:
- Paper CTD to eCTD conversion
- eCTD preparation and validation
- Submission to FDA
- Staff augmentation
Providing our clients with options to fit their individual needs including:
- SPL Creation from MS Word
- ACA 6004 Drug Sample Submission
- Establishment XML Creation
- Submission to FDA
- Staff augmentation
Providing our clients with Regulatory and Technical expertise to develop various productivity tools, submission tracking databases, SOP training Databases and other custom tools required.
Other IT services available:
- Software support
- eCommerce
- Website development
- Website maintanence
We evaluation your current process and help refine them to be more efficient and effective. When implementing eCTD or other new software, it's a perfect time to evaluate and redesign how business is being done. Let us help!
Standardizing current publishing, submission and archival process increases productivity and eliminates redundance.
Work smarter, not harder!
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