Saravanan Muthaiah

Background

About Saravanan Muthaiah

Results-driven professional with a proven track record as Associate Vice President. Specializing in the pharmaceutical, nutraceutical, and medical device industries, I excel in navigating regulatory landscapes and ensuring compliance with industry standards such as GLP, 21 CFR Part 58, 21 CFR Part 11, eCTD, SEND data set and NABL ISO 17025:2017. My expertise extends to NDA/ANDA/505(b)(2) submissions, CDSCO/RCGM, USFDA GRAS assessments and EFSA compliance for novel food. I bring extensive experience in non-clinical toxicology, risk assessment, leachable/extractables, and impurity analysis. With a focus on IND candidate development and NDA submissions (505(b)(1) & 505(b)(2)), I've successfully navigated the complexities of regulatory pathways. My expertise further extends to medical devices, overseeing biocompatibility studies in adherence to ISO standards. In the realm of biologics, I've contributed to the development of biosimilars, peptides and vaccines. Additionally, I have a comprehensive understanding of REACH/EFSA nonclinical studies and am dedicated to GLP compliance. My proficiency spans diverse sectors, including pharma, bio-pharma, medical device testing, nutraceuticals, herbal drugs, food and feed ingredients, impurity qualification, and CBD/THC testing. Committed to delivering high-quality testing services, I have successfully overseen processes and maintained a keen focus on customer satisfaction. Let's connect to explore opportunities for collaboration and business growth within the dynamic realms of technical sales, regulatory compliance, and cutting-edge testing services. High-quality delivery is the cornerstone of my Business Development approach.