Kalpita is currently employed at Hikma Pharmaceuticals, specializing in combination products. Her main area of expertise revolves around developing and successfully launching nasal sprays, inhalation devices, and similar offerings. With over 14 years of experience in Quality Assurance and Regulatory Affairs within the pharmaceutical and medical device industries, Kalpita strongly focuses on device development, technology transfer, product launches, and quality auditing.
Throughout her career, Kalpita has played a leading role in supporting the introduction of high-risk, complex, and emergency-use medical devices. She has made notable contributions to global markets by successfully launching critical respiratory in-vitro diagnostics (IVD) kits such as SARs-COV-2 IVD kits during crucial pandemic years.
Kalpita’s dedication to maintaining exceptional quality standards and ensuring regulatory compliance has significantly impacted the industry. She is a long-time American Society of Quality (ASQ) member. She is certified as Quality Manager/ Organizational Excellence (CQM/ OE), Quality Engineer (QE), and Certified Quality Improvement Associate (CQIA) by ASQ and holds Lead Auditor for ISO 13485:2016 and MDSAP credentials. Her extensive experience and technical proficiency allow her to effectively navigate the complex landscape of pharmaceuticals and medical devices. She consistently provides innovative solutions to meet the market’s evolving needs, solidifying her reputation as a trusted professional in her field.
