Balaji has about three decades of experience in the pharmaceutical industry spanning across sterile and non-sterile drug substances, oral dosages, parenteral and vaccines. At InACE, he is responsible for strategy and execution. 

Balaji is a subject matter expert (SME), for quality system topics on microbiology, sterility assurance, aseptic oversight and validations. He is an astute consultant, meticulous auditor and a passionate trainer for the pharmaceutical, biotech and medtech industries.

Balaji has supported clients for inspection readiness for US FDA, MHRA, EU GMP, TGA, ANVISA and for remediation activites.

Balaji is a CQI IRCA certified Lead Auditor for ISO 9001:2015 and ISO 13485:2016. He holds a masters in microbiology from Madurai Kamaraj University.