Regulatory Submission and publishing Services
Expertise and Ability to Successfully Publish submissions
Global eCTD Publishing and Submission
ekaGRA helps you overcome challenges that continually arise in an environment of ever-evolving global regulation changes. With innovative solutions and extensive experience, ekaGRA’s submission publishing service experts are available to partner with you to create the optimum solution for any Market Authorization/Clinical document submission and publishing needs. Specializing in global development, ekaGRA’s submission publishing services team can help plan, manage and prepare for global, multicountry simultaneous or sequential filings and meet all product development milestones. ekaGRA is 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:
Comprehensive Services
CUSTOMIZED TO MEET YOUR NEEDS
Content Authoring
CMC, Clinical & Non-Clinical documents authoring
Submission Publishing
Document and Dossier Publishing
Submission Management
Global Submissionse eCTD/NeeS/Paper
Global submission Management
Efficient, effective multicountry filing
- 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
Meet Our Clients
They Believe In Us
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What do we do?
- Reulatory Intelligence
- Regulatory Information Management
- Reporting
- IDMP
- Publishing
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- Biologics
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- Nutraceuticals
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