About
Dr. Anand Babu Vangala
Director Centre of Regulatory Affairs

Dr. Anand Babu Vangala is a seasoned expert in regulatory affairs and clinical research, with
extensive experience of 8 years in managing the regulatory landscape for in vitro diagnostic
(IVD) devices. As the current Head of Regulatory Affairs at Neuome Technologies Pvt Ltd.,
Bangalore, since December 2021, Dr. Vangala has led numerous successful regulatory
submissions, including ISO 13485 certifications, FDA, and CDSCO applications. His
expertise in Quality Management Systems (QMS) and TUV audits has been crucial in
maintaining compliance with global standards.
Dr. Vangala’s role involves the meticulous preparation and submission of regulatory
documents, managing communication with regulatory bodies, and ensuring that all products
adhere to the necessary regulations. His deep understanding of regulatory requirements and
proficiency in handling complex regulatory processes has significantly contributed to the
company’s growth and compliance.
Prior to his current position, Dr. Vangala served as a Regulatory Affairs Associate at Berlin
Heart GmbH, where he was instrumental in the regulatory aspects of medical devices. His
responsibilities included preparing regulatory submissions, coordinating with regulatory
authorities, and ensuring that all products met stringent regulatory standards.
In addition to his regulatory expertise, Dr. Vangala has significant experience in clinical
research. As a Clinical Research Associate at the mibeg Institute of Medicine in Cologne, he
was responsible for planning and conducting clinical trials, writing clinical trial protocols,
obtaining ethics committee approvals, and preparing essential study documents such as
Informed Consent Forms (ICF) and Case Report Forms (CRF). His thorough knowledge of
ICH-GCP guidelines and clinical trial management has been pivotal in the successful
execution of clinical studies.
Dr. Vangala holds a Ph.D. from Heinrich Heine University, Düsseldorf, where his research
focused on the role of the Vip1 kinase family member Asp1 in the morphogenesis of the
fission yeast Schizosaccharomyces pombe. He also earned a Master’s degree in
microbiology from Friedrich Schiller University, Jena, with his thesis research conducted at
the Karlsruhe Institute of Technology, investigating antibiotic resistance in Pseudomonas
aeruginosa.
His dedication to professional development is reflected in his certifications in Good
Manufacturing Practice, clinical research skills, and project management. Dr. Vangala’s
technical expertise spans molecular biology techniques, protein methods, gene expression
analysis, and the design and evaluation of experiments.
An active contributor to the scientific community, Dr. Vangala has presented at numerous
conferences and published several papers. His extensive experience in regulatory affairs,
clinical research, and compliance with international standards makes him an outstanding
candidate for a faculty head position, where he aims to continue advancing the field of
clinical research and regulatory science.