Unannounced visits from inspectors are a routine possibility for FDA-regulated facilities, tasked with ensuring compliance. When a facility fails to meet the required standards, it receives an FDA Form 483, a formal report highlighting the deficiencies.
According to Rashmeet Sangari, the founder of SkyPreme Resolve, approximately one-third of these inspections result in negative reports. Companies are under immense pressure to respond swiftly, as failing to address the issues can lead to serious consequences.
Armed with two decades of expertise in life sciences supply chains and operations, Sangari was well-equipped to tackle this issue. SkyPreme Resolve emphasizes preparedness, aiming to eliminate surprises during inspections and enhance pharmaceutical safety and reliability.
The core technology is a regulatory decision engine, which Sangari describes as self-optimizing, built on a decade of inspection data.
“I care about the patient and that’s why I’ve been in the healthcare industry,” Sangari stated. “This is a personal mission to make sure the next plant doesn’t go dark and that the next patient looking for medicine doesn’t find an empty shelf.”
Sangari’s innovation was recognized at the 2026 StartUp Lehigh Valley event, where she secured the grand prize, winning $20,000 in funding from Lehigh University to expand her business.
This Shark Tank-style competition, hosted during Musikfest, provided a platform for entrepreneurs across various industries to present their innovations to expert judges and a live audience.
Seven entrepreneurs showcased their ideas, vying for over $26,000 in prizes. SkyPreme Resolve not only claimed the top award but also earned six months of direct support from Lehigh Ventures Lab.
Other notable winners included Acute Baby Co., awarded $3,000 by Moravian University for The Wedge, a breastfeeding support tool, and LegalPocket.ai, which received the $5,000 Innovation Award from Ben Franklin Technology Partners of Northeastern Pennsylvania.
The Audience Choice Award, determined by live and online viewers, went to JAERIMY, Inc., for their time-based safety check-in app, ERIC, designed for individuals living alone, earning them $1,000.
Additional finalists included Coul Street, Inc. with an EV charger, NextPick.io offering a college recruiting expertise marketplace, and Racklify, Inc., which supports logistics and fulfillment needs.
Each finalist was given three minutes to pitch their startup to this year’s judges, followed by seven minutes of Q&A.
The judging panel featured Lehigh alumna Olivia (Abrams) Bleiweiss, CEO and co-founder of TiCK MiTT, who had previously appeared on Shark Tank in 2025. “It’s all about passion,” Bleiweiss remarked. “It’s very difficult to go from 0-100 without being extremely passionate about what you do.”
Returning for its second year, StartUp Lehigh Valley bridges the local community with entrepreneurship and innovation during the vibrant setting of Musikfest.
“We’re excited to have this here in the Musikfest Cafe, during Musikfest, which brought in last year 1.4 million people,” said Kassie Hilgert, president of ArtsQuest. “If we can expose them to the assets here in Bethlehem, beyond music stages, that is a win for all of us for workforce development.”
Embracing the entrepreneurial spirit, several Lehigh alumni with startups participated in the event at the Lehigh Lounge, located on ArtsQuest’s first floor, where attendees could explore their products and engage in activities organized by the P.C. Rossin College of Engineering and Lehigh Athletics.
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