Kosha Shah

About Kosha Shah

Pharmaceuticals and Biotechnology industry as a product development and regulatory professional with extensive working experience in the area of Pre-formulation and Formulation Drug Product Development work using Quality by Design (QbD) and Design of Experiments (DOE). Focusing on product development to drive commercially valuable and cost-effective drug innovation using various novel platform technologies to support projects from concept through new product launches for small and large molecules. I have nearly 10 years of Pharmaceutical sciences experience with Doctor of Philosophy specialization in Pharmaceutical Sciences and material sciences.I am an experienced, accomplished, and detailed oriented experienced formulation research leader for drug product CMC development strategy and execution of early- to late-stage (formulation and analytical) programs with internal and/or external teams for solid oral and liquid dosage forms. This includes Tablets, Capsules, Mini-tabs, Nano-formulations, Microemulsion, Ophthalmic emulsion, Suspension and Liposomes, sterile (Parenteral) and non-sterile formulations. Hands on experience on formulations development of amorphous solid dispersion using spray drying technique, hot melt extrusion and super critical fluid technology. Authored and Supported FDA Pre-IND, EOP 2, and Pre-NDA with Type B and Type C meeting activities and played key roles in IND, BLA, NDA, 505(b)(2), and ANDA submissions. Author relevant documents and module 3 for drug product and drug substance required to support INDs, NDAs and BLAs.

Experience

1. Senior Consultant- Regulatory Sciences

   ProPharma

   Apr 2022 — Present · US

Education

• Long Island University

  Doctor of Philosophy (Ph.D.), Pharmaceutics

  2011 — 2014

• LIU Brooklyn

  Master's, Pharmaceutics

  2008 — 2010

• Nirma University

  Bachelor's, Pharmacy

  2004 — 2008

Skills

• Analytical Techniques
• Thermal Analysis (Dsc)
• Microdialysis
• Regulatory Affairs
• Drug Delivery
• Solid Amorphous Dispersions
• Pharmaceutical Industry
• Sop
• In Vitro
• Standard Operating Procedure (Sop)
• Project Management
• Assay Development
• Dissolution
• Business Strategy
• Differential Scanning Calorimetry
• Formulation
• Time Management
• Kinetics
• Spectrophotometry
• Organizational Leadership
• U.s. Food and Drug Administration (Fda)
• Pharmaceutics
• Drug Discovery
• Crystallization
• Spray Drying
• Pharmaceutical Research
• Validation
• Life Skills
• Research