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Kalpita Mehta is a combination product and medical device expert for one of the top 10 generic prescription medication manufacturers in the United States. As an engineering, regulatory, and quality management professional and medical device professional, she plays a critical role in developing and launching complex pharmaceutical and drug-device combination drug products for multiple therapeutic uses. Billions of people worldwide have benefitted from her contributions involving in-vitro diagnostic products, such as the launch of COVID-19 testing kits during the pandemic, combating opioid overdose surgical products such as wheelchairs, and other medicinal devices that alleviate upper respiratory and gastrointestinal symptoms and other critical disease states, among many other medications and products.

Kalpita additionally applies her significant experience in ISO standards for Medical Devices, Risk Management, and Lifecycle Management to promoting public safety by ensuring end-to-end quality and product compliance with the U.S. Food and Drug Administration (USFDA). Among her numerous professional licenses and certifications, she is an ASQ Certified Manager of Quality/Organizational Excellence, an ASQ Certified Quality Engineer, an ASQ Certified Quality Improvement Associate, a Six Sigma Greenbelt, and the Global Exemplar Lead Auditor for ISO 13485:2016.

Kalpita holds a registered pharmacist degree from India and earned a master’s degree in biotechnology entrepreneurship from Case Western Reserve University. She is a member of the Regulatory Affairs Professionals Society (RAPS) and serves as a participant on the Steering Committee CoP Combination Products for the International Society for Pharmaceutical Engineering (ISPE), focused on engaging industry leaders to discuss hot topics unique to combination products. Kalpita also serves as a Volunteer Drug Device Combination Product Expert Advisor to the United States Pharmacopoeia (USP) sub-committee, a nonprofit organization that sets quality standards for medicines and other healthcare products in the U.S.

Q: Kalpita, let’s start with some background. In about two decades your career has evolved from a pharmacy degree to spearheading drug quality and regulatory initiatives across global markets. Was your plan always to enter the pharmaceutical manufacturing industry? Tell us about your path.

KM: I embarked on my career in the Pharmaceutical industry, specifically as a Regulatory Affairs and Quality Systems Specialist. In this role, I was involved in ensuring compliance with regulatory standards and creating technical packets for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for FDA filing applications. After gaining valuable experience in this area, I transitioned to Medical Devices Quality Engineering for about eight years. So, with my extensive experience in both industries, that paved the way for a new opportunity and focus on combination products, which utilizes both drugs and devices. Ultimately, this career progression brought me full circle as I returned to the pharmaceutical industry.

Q: You now have a vast scope of responsibilities associated with improving the quality of medical devices and launching pharmaceuticals in the U.S. How did you gain your extensive experience in quality engineering, and how do you apply it in your work?

KM: My experience in quality engineering has deeply instilled the principles of “Right The First Time (RTF)” and a continuous improvement mindset. These principles are crucial in both Pharma and Medical Devices Quality, ensuring that all standards are met on the first attempt, thereby eliminating rework and minimizing defects through rigorous checks and balances.

Moreover, my active participation in large industry quality and regulatory-focused organizations, whether as an industry contributor or a volunteer expert advisor, keeps me at the cutting edge of hot topics, technological advancements, and industry challenges. This involvement has equipped me with invaluable insights into regulatory strategy and navigation, which I leverage daily to drive quality and compliance in my core job, creating a significant impact on the industry.

Q: What are Combination Products, and why are they regulated by the USFDA? Can you give us some examples of your groundbreaking contributions in this area?

KM: Combination products are composed of two or more different types of medical products, such as a combination of a drug, medical device, and/or biological product. These types of products are particularly complex and therefore require deep expertise. It is mandatory for manufacturers to comply with FDA requirements, to ensure these products are safe and effective for the U.S. population. Compliance requires that combination products go through checks and balances in manufacturing, to meet product quality standards for patient safety. For example, an underfilled device could lead to a negative health impact on the patient, or an overfilled device could lead to an overdose. Or if equipment is not properly sterilized and decontaminated, microbial growth could negatively impact users.

Combination products are particularly complicated because experts must manage risk to ensure that there are no adverse interactions between the drug, its excipients, and the device constituents. The USFDA requires manufacturers to complete extensive device design verification and validation. These requirements are newer to the drug industry within the last five years, and this presents regulatory challenges for complex products with unique manufacturing technology. Regulatory requirements could vary with the complexity of the device, from low-risk class devices to high-risk class devices. If a pharmaceutical manufacturing company lacks documentation or facility compliance, the FDA could find a product application deficient or may find the facility non-compliant, which could ultimately delay or stop beneficial medical products from being launched in the U.S.

I leverage my extensive education and experience in medical engineering and chemistry to improve the effectiveness and quality of medical devices, pharmaceuticals, and the devices that help administer drugs. For example, I recently supported the launch of an emergency use drug-device combination product which helps to address the opioid crisis, respiratory system, and central nervous system depression. This research enables the sale of more affordable opioid drugs. I have also worked on combination products in the past, such as generic Advair, which is an asthma pharmaceutical used by millions of patients. One of my most critical contributions earlier in my career was expediting the launch of the SARs-CoV-2 COVID test during the pandemic, which we know saved countless lives.

Q: What is your quality role in bringing new, advanced products that treat medical conditions and diseases to market, and how do you support public health?

KM: I contribute to quality and regulatory compliance through multiple channels. As a combination product and medical device subject matter expert, I spearhead strategic initiatives that enhance compliance, streamline FDA filings, and accelerate time-to-market for critical medical devices. I develop, implement, and support the risk management and lifecycle management of a quality management system, processes, and procedures, to be compliant with all relevant combination product and medical device regulations. Additionally, I develop and drive a risk management approach, and work within a Center of Excellence to share and align on best practices across our company’s operating units. I also contribute to relevant quality governance meetings.

I furthermore support public health through my advisory roles with USP and ISPE, further pursuing engagement via articles, my research publications, my presentations, and panel discussions at pharmaceutical industry conference. At USP this involves writing new chapters about drug-device combination products. At ISPE my role includes reviewing and commenting on FDA draft guidance, benchmarking manufacturing best practices, and educating industry leaders and other stakeholders. I also have an opportunity to publish an article with multiple online forums that I am looking forward to this year, as well as a panel discussion in Discovery and Development at the US 2025 Formulation and Drug Delivery conference, to be held October 2- 3, 2025 in San Diego, California.

Q: What are some of the greatest quality challenges you face in your role?

KM: I believe that the greatest quality challenges involve adapting to evolving agency requirements, because change is constant in this dynamic space. Continuous learning is the backbone of adaptability in quality assurance, while maintaining patient focus is essential to delivering products that are safe and effective to use.

Q: Do you have any advice for other quality professionals interested in product manufacturing?

KM: Effective quality leadership in the manufacturing area demands innovative problem-solving skills, expert scientific knowledge, relevant experience, and a deep understanding of quality tools to quickly resolve issues that impact component and product quality. Throughout my career, I’ve had to create quality systems from the ground up, including components such as sampling, nonconformances, risk analysis, internal and external audits, documents remediation, and more. This requires strong technical expertise, as well as the strategic planning and leadership skills that have enabled me to lead cross-functional teams and drive operational excellence. My current role allows me to apply my pharmaceutical, biomedical engineering, quality framework, and design expertise, and knowledge of product launch processes, to close compliance gaps and support complex product launches. Working in pharmaceutical manufacturing, the responsibilities associated with quality and patient safety are great, but so are the rewards. It is very meaningful to know that our work helps to significantly improve the quality of life for people who suffer from various medical conditions, and often saves lives.