Profile Details

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USD 50 /hr

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Hire SIMONA S.

Romania

USD 50 /hr

Freelance RAQA and product development

Profile Summary

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.

Subject Matter Expertise

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

Services

• Writing
• Research
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Product Development Formulation

Work Experience

RAQA Consultant

smarts regulatory consulting

March 2016 - Present

Education

M.S. in Pharmaceutical

University of Medicine and Pharmacy, Bucharest, Romania

September 1998 - June 2001

Certifications

• Certification details not provided.