プロフィール詳細

プロジェクトを作成

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SIMONA S.に依頼

Romania

Freelance RAQA and product development

プロフィール概要

Deliver wide range of regulatory affairs services, including CTD audit dossier, proof reading, translations, variations, document compilation nonclinical / clinical overview drafting, licence procurement for medical devices distributors, and national legislation procedure information gathering. Execute various operations by implementing best practices in pharmacovigilance activities for clients / audits to improve public health and safety. Conduct numerous CSV procedures on-site in adherence to 21 CFR Part 11, Annex 11, and GAMP5 to attain compliant computerized systems. Product development for food supplements and cosmetics.

専門分野

• ★ Regulatory Affairs
• ☆ Product Development
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Medical Writing

サービス

• Writing
• Research
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Product Development Formulation

職務経験

RAQA Consultant

smarts regulatory consulting

3月 2016 - 現在

学歴

M.S. in Pharmaceutical

University of Medicine and Pharmacy, Bucharest, Romania

9月 1998 - 6月 2001

認定資格

• 認定資格の詳細は未入力です。