Medical Writing

We offer Comprehensive, reliable medical writing support to expedite submissions and approvals. Our medical writing services are offered as an integrated part of our clinical development expertise and include Protocol development, ICF, Investigator Brochure, Clinical Study Report Writing, Regulatory Writing, Safety Documents.

Medical Writing Services Include:

Phase I-IV protocol development

Case Report Form design

Regulatory applications and submissions

Phase I-IV integrated clinical statistics reports

Clinical study reports according to ICH E3 and eCTD format

Translations of regulatory documents

Investigator's brochure development

Informed Consent Form including local language ICFs (prepared and reviewed by the relevant country)

Case narratives

SOP development

Leaflets, buclets and posters

Serious adverse event narratives

Pre- and post-approval aggregate safety reports

Our partners

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משרד ורשה

יאנה פאולה II 27

00-867 ורשה, פולין

+48 32 227 20 05

משרד ראשי

רחוב דזבונקובה 104

43-100 טיכי, פולין

+48 32 227 20 05

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