Profile Details

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USD 40 /hr

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☆☆☆☆☆

Hire Dr. Rezvan H.

United Arab Emirates

USD 40 /hr

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

Profile Summary

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.

Subject Matter Expertise

• ☆ 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

Services

• Consulting

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

Work Experience

Independent Biopharmaceutical Consultant (Remote)

Remote

June 2025 - Present

Qualified Person & Regulatory Affairs

Nojine Zist Pharmed

May 2025 - Present

Qualified Person

AryoGen Pharmed

January 2026 - January 2026

Formulation, CTD & CMC Supervisor

AryoGen Pharmed

November 2020 - May 2025

Formulation, CTD & CMC Specialist

AryoGen Pharmed

May 2020 - November 2020

Analytical Method Development Specialist

AryoGen Pharmed

July 2019 - May 2020

Quality Control Specialist

AryoGen Pharmed

February 2019 - July 2019

Qualified Pharmacist

Community pharmacy

July 2017 - February 2019

Education

Doctor of Pharmacy

Ahvaz Jondishapur University of Medical Sciences - Iran

October 2012 - December 2018

Certifications

• GMP Audit and Inspection

  AG

  January 2021 - Present

• CTD Preparation & Submission

  IFDA

  January 2020 - Present