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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Have a business query? Lets talk.

info@ekagrasolutions.com

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