プロフィール詳細

プロジェクトを作成

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Dr. Rezvan H.に依頼

United Arab Emirates

Biologics & Plasma-Derived Products CMC & Regulatory Consultant | CTD | GMP | Comparability | Stability | mAbs | IVIG |

プロフィール概要

Biopharmaceutical CMC and Regulatory consultant with hands-on experience in biologics, biosimilars, and plasma-derived products. My background includes GMP compliance, Qualified Person (QP) responsibilities, batch release, CTD (Module 2 & 3) preparation, comparability studies, stability programs, and technology transfer. I have supported multiple monoclonal antibodies, recombinant proteins, Albumin, and IVIG products across the full lifecycle — from R&D and formulation development to regulatory submission and commercial manufacturing. I help biotech and pharmaceutical teams with audit-ready documentation, successful submissions, and practical CMC strategies. Available for remote, project-based consulting.

専門分野

• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Biosafety Testing
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ Biologic & Biosimilar Manufacturing

サービス

• Consulting

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

職務経験

Independent Biopharmaceutical Consultant (Remote)

Remote

6月 2025 - 現在

Qualified Person & Regulatory Affairs

Nojine Zist Pharmed

5月 2025 - 現在

Qualified Person

AryoGen Pharmed

1月 2026 - 1月 2026

Formulation, CTD & CMC Supervisor

AryoGen Pharmed

11月 2020 - 5月 2025

Formulation, CTD & CMC Specialist

AryoGen Pharmed

5月 2020 - 11月 2020

Analytical Method Development Specialist

AryoGen Pharmed

7月 2019 - 5月 2020

Quality Control Specialist

AryoGen Pharmed

2月 2019 - 7月 2019

Qualified Pharmacist

Community pharmacy

7月 2017 - 2月 2019

学歴

Doctor of Pharmacy

Ahvaz Jondishapur University of Medical Sciences - Iran

10月 2012 - 12月 2018

認定資格

• GMP Audit and Inspection

  AG

  1月 2021 - 現在

• CTD Preparation & Submission

  IFDA

  1月 2020 - 現在