K Anand is post graduate in Analytical Chemistry by training from University of Bombay. He has been a senior Pharma Industry professional for over 35 years in the area of Quality and Regulatory Affairs.
K Anand has risen from ranks in Quality, and has been instrumental in setting up International Quality standards from the start-up phase in large reputed Pharma companies like Lupin, Glenmark and Famy Care (now Mylan). He also has the distinction of integrating Quality and Regulatory Affairs functions in Glenmark, Famy Care, Cadila Healthcare (Zydus) and Dr Reddy’s Laboratories which has paid rich dividends in efficiency of filing DMFs, ANDAs, Deficiency management, adoption of QbD approaches in development/scale up besides upgrading the Quality Management processes.
He has led large teams in all these Companies to successful regulatory inspections (US, EU, MCC, TGA, ANVISA, WHO Geneva….etc) on several occasions and has built robust and sustainable compliance ethics, data integrity policies, continuous improvement of cGMP systems. He has immensely contributed to the development of skill level of subordinates/teams to meet the challenges of ever changing/evolving GMP systems. He has deep understanding of complexities in related functions of Pharma business like Development, Manufacturing, Marketing/customer expectations, which helps in taking a 360 deg approach to finding solutions to complex problems.
K Anand’s core competence has been to evolve QbD approaches during Development & Regulatory Filing of Dossiers, Efficient deficiency management, Life cycle management of products, Good Laboratory Practices implementation, Development of robust and sustainable Quality Management Systems, preparing facilities for “Any Time Readiness” of Regulatory inspections, post inspectional Remediation plans for implementing CAPAs, People development for competency build up.
K Anand enjoys great respect within Pharmaceutical industry in India for his contribution to team building, transparency in GMP, ability to liaise with Regulators effectively on handling complex problems. He has also earned credibility with International and National Regulatory agencies for effective liaison for the cause of product Quality and GMP systems.