Rahul has over 20 years of pharmaceutical experience. He has led IND, NDA, and ANDA projects from the stages of pre-development, development, filing, and FDA review and approval. He has led clinical IT projects that included drug safety systems, statistical analysis, and portfolio management. He has a thorough understanding of different phases of clinical studies and protocols and has ensured the implementation of company-wide quality systems and policy compliance to FDA, QSR, ISO 9001/13485 and EN46001 as they related to supplier management