Regulatory Affairs Consultant
Ashwini Kulkarni, MSc
Regulatory Affairs expert
Ashwini is part of the non-active Medical Device Regulatory team. She has hands-on experience in various medical device projects for regulatory submissions including writing dossiers, technical writing, gap analysis, query handling, conducting literature-based studies, project coordination, and support. Her regulatory experience is with implantable devices, devices utilizing biological tissue (animal/human) and devices which incorporate ancillary medicinal substances. Besides the European market, she has worked on various projects leading to successful approval in various countries around the world.
Prior to Qserve, she worked with various organizations in the Netherlands and in India in both medical device and pharmaceutical sector. Her pharmaceutical regulatory affairs experience is in building CTD, mainly CMC work for the innovator, generic products, IMPDs for clinical trial applications, post-approval variations, site transfer, query handling and international regulatory submissions.
Her background in pharmacology, hands-on experience with writing both pharmaceutical and medical device dossiers provides an advantage in case of combinations products. She has analytical thinking and problem-solving approach to her work.
Ashwini is a trained Pharmacist with Master’s degree in Pharmacology.
Ashwini about working at Qserve:
‘’Qserve offers an energetic environment with people from various cultures and educational backgrounds. In an increasingly challenging and changing environment, this diversity offers an enormous advantage.’’
Learn more about our services within Regulatory Affairs