Drug Development and Regulatory Consultant

Expertise

Thorough understanding of regulatory requirements of CMC package including characterization studies of MDIs & Nasal Spray products for Advanced Markets i.e., US , EU, LATAM and other similar markets.
Thorough understanding of In vitro BA BE studies required for Inhalation and Nasal Spray products for advanced markets.
Formulation and process development of HFA based pMDI, Nasal Spray and DPI formulations for Domestic, ROW, LATAM and advanced markets.
Thorough understanding of CMC package for solid orals, liquid orals and Parenteral products.
Facility planning, creating, installation & commissioning for commercial production of pMDIs, Nasal Sprays and DPI products.
Facility planning designing and commissioning of product development (formulation and analytical) laboratories to cater to all markets.
Third party ANDA adequacy and accuracy review ( onsite or offisite)