Asif Ali

• Design and Development of oral solid dosage forms of Immediate Release and Modified release for US, Canada & EU markets. • Design and Development of Medicated Chewing Gums by-passing the formulation technology used by the innovator and successfully scaled-up the process to commercial scale.

• Prospection of raw materials (COA evaluation and validation) including API and Excipients to be used in the formulation. • Evaluation of Manufacturing line in the production required to scale-up the product from lab scale to production scale • Patent evaluation, literature search and preparation of formulation strategies. • Conducting Pre-formulation studies, designing of prototype formula, optimization and finalization of formula composition and manufacturing process.

• Applying QbD principles as per FDA/ICH guidelines in developing high quality generic products. • Development of lab-scale batches • Execution of scale up and submission batches • Stability studies on Innovator and finished product as per ICH guidelines • Sending the samples to BA/BE studies