CRAMSN is a trusted One-Stop-Shop CRO and CDMO service partner enabling pharmaceuticals, biotech, and consumer health companies to accelerate delivery of affordable medicines to end patients with speed and agility.

Responsible for the R&D/AR&D/IPM and process Scale-up departments to identify, develop, and deliver active pharmaceutical Ingredients complying to IP/RA/EConomics. Involved in activities from product selection to commercialization. product selection, route selction, process development, patent drafting, patent filing, scale up studeis, implementation of the process in plant, commercialization, process validation, DMF filing, etc., Development of IP/Regulatory complying quality drug substance.

Responsible for the R&D/AR&D/IPM and process Scale-up departments to identify, develop, and deliver active pharmaceutical Ingredients complying to IP/RA/EConomics. Involved in activities from product selection to commercialization. product selection, route selction, process development, patent drafting, patent filing, scale up studeis, implementation of the process in plant, commercialization, process validation, DMF filing, etc., Development of IP/Regulatory complying quality drug substance.

• Involved in Process development of the API (Active pharmaceutical ingredients) for regulated and less regulated markets. Job role involved guiding the teams to develop non-infringing route of synthesis and supporting DMF/ANDA submissions complying with time, cost, IP and RA. • Successfully handled and completed around 20 Active Pharmaceutical Ingredients (API’s) products for regulated market.• Handled three teams each consisting of one group leader and 8 chemists in different capacities. Each team develops around 2.5 to 3 products/year. Developed around 20 products with the creation of 35 patents and 12 publications in reputed international and national journals of chemistry. •Championed the activity of creating "center of excellence in polymorphism, Biocatalysts and chiral Chemistry” which supports and resolving the related issues in all the products organizational wide.

Involved in Process development of APIs complying with c-GLP and ICH guidelines for regulatory markets and DMF requirements. Developed around 8 products starting from literature review to commercialization phase successfully. Major activities of the job role involved literature search/survey, literature analysis of the product with respect to process infringement analysis and polymorphism, conducting the feasibility experiments, optimization of the process, piloting, costing, and analyzing the scale up related issues. Transfer of scaled-up process to manufacturing facility without any issues till finalization of the process validation.