Ali Mohamadi

About Ali Mohamadi

Experienced CMC Reviewer at the FDA with regulatory expertise in chemistry…

Experience

1. Cmc Reviewer of New Drugs

   FDA

   Jan 2018 — Present

   Review chemistry, manufacturing, and controls (CMC) information of Investigational New Drug (IND), New Drug Application (NDA), Drug Master File (DMF), pre-IND and pre-NDA meeting background materials, IND and NDA amendment, NDA supplement, expanded access submission, premarket notification (510(k) or PMN), premarket approval (PMA), Investigational Device Exemption (IDE), and De Novo request.\\\\n• Respond to sponsors and applicants\' questions regarding CMC requirements of regulatory submissions in type A, B (pre-IND, end-of-phase 1, end-of-phase 2 and pre-phase 3, pre-NDA), and C meetings.\\\\n• Represent the FDA\'s CMC team in internal and external meetings.\\\\n• Review CMC sections of drug labeling (prescribing information, carton and container labels, patient information, and instruction for use).\\\\n• Collaborate with cross functional teams at FDA to reach regulatory decisions. Collaborations include (a) Office of Testing and Research (OTR) to verify analytical procedures for complex drug products,(b) Office of Pharmaceutical Manufacturing Assessment (OPMA) to (i) confirm the compliance of facilities,(ii) control microbial limits of sterile products, and assess the risk of nitrosamines formed in the process,(c) Office of Biotechnology Products (OBP) to assess novel excipients,(d) Division of Pharmacology Toxicology for Cardiology, Hematology, Endocrinology, and Nephrology (DPTCHEN) to assess the qualification of impurities (organic, elemental, leachable, and nitrosamine),(e) Center for Devices and Radiological Health, Office of Product Evaluation and Quality (CDRH, OPEQ) to assess the drug quality of combination drug products.\\\\n• Analyze pre-approval inspections (PAI), FDA 483 forms (inspectional observations), responses to FDA 483 forms, establishment inspection reports (EIR), field alert reports (FAR), and Corrective and Preventive Actions (CAPA).\\\\n• Serve as a Center for Drug Evaluation and research (CDER) liaison on USP’s expert committees and expert panels.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Skills

• Abbreviated New Drug Application (Anda)
• Protein Chemistry
• Research
• New Drug Application (Nda)
• Western Blotting
• Computational Chemistry
• Pcr
• Regulatory Affairs
• Fda
• Organic Synthesis
• Nmr Spectroscopy
• Ab Initio
• Heterocyclic Chemistry
• Lcms
• Fluorescence Microscopy
• Verification and Validation (V&V)
• Lanthanide Chemistry
• Ir
• Uv/Vis
• Teaching
• Method Development
• Photochemistry
• Molecular Cloning
• Dft
• Dna Ligation
• Pharmaceutical Industry
• High-Performance Liquid Chromatography (Hplc)
• Organic Chemistry
• Fret
• Gc-Ms
• Dna Extraction
• Pymol
• Uv/Vis Spectroscopy
• Organometallics
• Fusion Quality by Design
• Matlab
• Gaussian 03
• Hplc
• Statistics
• Biochemistry