Divyang joined Delta Tetra Consultancy in early 2019, supporting the company with all things regulatory compliance and quality assurance.
Div has over 20 years of experience in Australian and global pharmaceutical markets, project management, regulatory compliance, quality assurance, as well as analytical and technology transfer operations.
Div interests extend into development and registration of pharmaceuticals and cannabis products. He has a successful history of speeding up drug development and approval of pharmaceutical products through his comprehensive understanding of the drug development and registration process from bench to commercialisation. His extensive knowledge of CMC documentation has allowed for seamless preparation of drug product TMFs for TGA submission, DMFs and INDs for US FDA fillings.
One of Div’s major achievements has been the successful management, scale up operations and regulatory compliance of large-scale international CBD (cannabidiol) projects. He has a wealth of experience in preparing licensing and Import/Export Application for cannabis, synthetic CBD API, CBD/THC oil, CBD flower for managing CBD projects.
Internationally, Div has led international inter-company technology transfer in North America, Europe and the Asia Pacific. Div’s experience in technological transfer of new products and processes from benchtop to pilot-scale has facilitated Australian and US clients to supply products for clinical trials and commercial supply.
He has led the production of commercial products and clinical trial materials in a variety of dosage forms in TGA and FDA approved facilities.
Div is responsible for all Regulatory Compliance and Quality Assurance at Delta Tetra.