プロフィール詳細

プロジェクトを作成

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Nancy Muthoni M.に依頼

Kenya

Regulatory affairs. Dossiers, CTD & eCTD module preparation, Regulatory submission backed by 8+ years experience.

プロフィール概要

I provide complete regulatory dossier services including CTD/eCTD preparation, document formatting, submission-ready PDF files, and label compliance support. My services include: CTD & eCTD module preparation (Module 1-5) Regulatory submission formatting Dossier compilation & indexing SOP & stability report formatting Compliance checking for packaging & labels Export documentation & product registration support Develop missing dossier sections like QOS, QIS , SmPC

専門分野

• ★ Pharmaceutical Regulatory Affairs
• ★ Regulatory Affairs
• ★ Medical Writing
• ☆ Clinical Trials
• ☆ Medical Content Writing
• ☆ Medical Content Writing
• ☆ Product Descriptions

サービス

• Writing

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, General Proofreading & Editing

職務経験

Regulatory Affairs Associate

WIN-PHARMA LIMITED

6月 2023 - 6月 2026

学歴

PHARMACOVIGILIANCE

CRK COURSES KENYA

10月 2025 - 12月 2025

認定資格

• Regulatory Affairs

  JEYFLEX CONSULTANTS LTD

  3月 2017 - 現在