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An IS0 9001:2015 Certified Institute

Publishing and Submissions

Sadhana Infotech has an experienced staff of industry-trained professionals to manage all aspects of electronic regulatory submissions. Our staff is located globally to support around-the-clock processing and quick turnaround times. MMS Regulatory Operations staff include:

Global Submissions Managers – global submission leadership and coordination for larger applications and applications filed in multiple regions or for projects that involve coordination of content from multiple CROs/consultants

Regulatory Operations Associates – submission project planning support and coordination of document and submission publishing, agency dispatch and regulatory document management and correspondence tracking

Document Specialists – formatting expert that ensures style guide and submission-ready standards have been applied to Microsoft Word documents.

Our team is expertise in performing different types of Publishing and Submission activities, Our services include:

  • Global eCTD Publishing and Submission Services
  • NeeS Submission
  • Paper Submission
  • Legacy Conversion
  • CSR-Report Level Publishing
  • Structure Product Labelling (SPL)
  • Drug Master File Submission (DMF)

Our Services