Regulatory is one of our core competencies. Our regulatory submission expertise is originated from our team's experience in filing numerous successful IND (CTX) and NDA (MAA) while employed by major US and European pharmaceutical companies and prior to joining Agno Pharma. This regulatory expertise is proven and fruitful in the last 6 years with successfully filing 10+ DMFs for Chinese API manufacturers, in support of our client's ANDA and 505(b)(2)-NDA submissions.