プロフィール詳細

プロジェクトを作成

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Pratibha P.に依頼

India

Regulatory Affairs & QMS Consultant | Dossier Preparation Specialist | Pharma QA Expert

プロフィール概要

With 20+ years of experience in the pharmaceutical and medical device industry, I specialize in regulatory dossier preparation (Tablets, Capsules, Injectables), QMS development, auditing, and GMP compliance. I have successfully supported companies in USFDA, EMA, TGA Australia, WHO, MCC South Africa, and MHRA UK regulatory environments. As a freelance consultant, I provide end-to-end support in dossier compilation, lifecycle management, DMF/CEP preparation, QMS documentation, and internal audits (ISO 9001 & ISO 13485). I bring deep expertise in process validation, technology transfer, elemental impurity evaluation (ICH Q3D), and readiness for regulatory submissions and inspections. My experience at Cipla (18+ years) ensures strong command over cGMP, product registration, change control, APQR, BMR/BPR review, CAPA, and quality system optimization. I help companies achieve regulatory submission-ready documentation, smooth audits, and compliant quality systems.

専門分野

• ☆ Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Technology

サービス

• Writing

Writing Technical Writing

職務経験

Consultant, Regulatory Affairs

FREELANCER PHARMA CONSULTANT

8月 2022 - 現在

学歴

Bachelor in Pharmacy

phar

7月 1998 - 5月 2002

認定資格

• Initial Certification

  Savitribai Phule University

  1月 2025 - 現在