Subash Das Email & Phone Number

Pharmaceutical professional having 18+ year of experience in Quality-by-Design (QbD) based drug product (oral solid and oral liquid dosage form) development for US, EU, Australia, and other regulated market. Expertise in drug product development as New Drug Application (NDA) and Abbreviated New Drug Application (ANDA).Good knowledge on intellectual property rights, bioequivalence study, invitro studies, process scale up & technology transfer, commercial launches, life cycle management, critical thinking, conflict resolution, team building, cost control, business proposal writing, project management, cGMP, and compliance.Expertise in New chemical entity (NCE) drug product (solid oral and oral liquid) development for various phase of clinical study (Phase I, II & III) and full support for CMC documentation for IND & IMPD filling. Sound knowledge on development of immediate release and modified release (extended release and delayed release) solid oral dosage forms like tablet, minitablet, pellets, capsule, and oral films. Good knowledge on development of oral liquid like solutions and suspensions. Successfully developed formulations for 10 NCE molecules for Phase I, Phase II and Phase III clinical trials. Good knowledge on bioavailability enhancement of insoluble NCE molecules. Developed formulation with 3-fold increase in bioavailability.Successful track record of product development and on time delivery of generic (ANDA) drug product of various dosage forms (immediate and modified release tablet and capsules) for regulated market (US/EU/Austalia and other). Expertise in handling post submission regulatory queries for smooth approval of products. Expertise in development of Patent non-infringement or design around” formulations of solid oral dosage for US/EU market. Successfully developed and filled more than 18 generic products for US and EU market.Expertise on development of 505 (b)(2) formulation. One extended-release formulation approved in US market and other products are under Phase III clinical trial.Sound knowledge on lyophilization cycle development for pharmaceuticals and biopharmaceuticals. Successfully developed lyophilization cycle for one biopharmaceutical long-acting injectable formulation.Expertise in scale up, technology transfer and commercial batch manufacturing for wet granulation,roller compaction and fluid bed processing. Successfully completed 23 projects for EU/US market.Have good knowledge on project management and business development with respect to CDMO business.