Susobhan Das, a distinguished biopharmaceutical expert with over two decades of experience, is poised to excel as a Principal Consultant for R&D and Regulatory affairs in the biopharma industry. With a PhD in Biotechnology and extensive leadership roles, including Founder/CEO of Amthera Life Sciences, Das brings exceptional depth of knowledge in early-stage biotherapeutics development and regulatory strategy to guide innovative treatments from concept to market.Professional Experience and ExpertiseWith a career spanning over two decades, Susobhan Das has amassed extensive experience in various aspects of biopharmaceutical development. His expertise is particularly notable in:Early-stage biotherapeutics developmentRegulatory affairs and strategyDrug development across therapeutic areas, including oncology and rare diseasesProject management in the pharmaceutical industryClinical development and optimization of R&D processesThis comprehensive skill set positions Das as an invaluable asset in guiding pharmaceutical companies through complex regulatory landscapes and accelerating drug development timelines. His strategic insights and deep understanding of global regulatory requirements are expected to be instrumental in bringing innovative treatments to market, ultimately benefiting patients worldwide.Throughout his illustrious career, Susobhan Das has held several key positions in the biopharmaceutical industry, showcasing his versatility and expertise:These roles have provided Das with a comprehensive understanding of the biopharmaceutical landscape, from early-stage research to strategic leadership, enhancing his ability to guide companies through complex regulatory and developmental processes.

SarGini Bio is engaged in Biopharmaceuticals R&D developing niche products and offering R&D services, Consulting other biotech sector businesses and imparting high quality industry relevant training programs

A. Biopharmaceutical Drug Development through CQA based product development (Hormones; Peptibody, Antibody, Growth Factors)B. Early Stage Process and Product Development starting from Cell Line DevelopmentB.Product Characterization: Analytical; Bio characterization; PK/PD; ImmunogenicityC.Non Clinical studiesD. Project Management: Timelines; Project Costing; COGS; Resources ManagementE. Regulatory submission (India; EMEA; US-FDA)

A. Development of Pharmacopeia standard for Biologics and Vaccines Physical Reference Standard for Purity and Content Documentary Reference Standard for Batch ReleaseB. Collaboration studies with WHO; NIBSC; IPC; USP-NF

A. Biopharmaceutical Product Development and Regulatory Support for Non Clinical and Clinical Studies. B. Method development, pre-validation and validation of pre-clinical studies: In vitro-in vivo biological assays (potency/efficacy assays). PK/PD and Immunogenicity StudiesC. Cell Bank Management: Manufacturing, Characterization and Storage of Bacterial and Mammalian Cell Banks (MCB, WCB, EOPC).

A. Independent research on Cancer Signal Transduction.B. Technical training to Graduate Students, Scientific communication & Submission of Research Grant Proposals.

Investigative research on protein-protein interaction and cancer signal transduction.Technical training to Graduate Students, Scientific Communication & Submission of Research Grant Proposals

Investigative research in Promoter and Enhancer Characterization for Tissue Specific Expression