Inquire for Consulting Services, QMSpace Digital Platform, and Digital Services
All-in-one best practice-based software solution and expert consulting for design controls, quality by design, risk management, cybersecurity, and safety assurance cases in compliance with the standards and regulations
OUR EXPERTS
Our global network of advisors, from industry and regulatory agency backgrounds, brings unmatched experience across pharma, biotech, medtech, and combination products. With decades of leadership in regulatory affairs, quality, product development, and commercialization, our experts help companies accelerate innovation, reduce risk, and achieve sustainable market success.
OUR EXPERTS
Our global network of advisors, from industry and regulatory agency backgrounds, brings unmatched experience across pharma, biotech, medtech, and combination products. With decades of leadership in regulatory affairs, quality, product development, and commercialization, our experts help companies accelerate innovation, reduce risk, and achieve sustainable market success.
All-in-one best practice-based software solution and expert consulting for design controls, quality by design, risk management, cybersecurity, and safety assurance cases in compliance with the standards and regulations
Inquire for Consulting Services, QMSpace Digital Platform, and Digital Services
TRUSTED BY:
Expert
Consulting
Our team provides comprehensive strategy and execution support, backed by deep industry expertise and resource connections
OUR JOURNEY
STAGE 1
Foundations & Alignment (2010 to 2016)
The company established credibility and deep integration with regulators. TurboAC began with the FDA CDRH OSEL’ introduction of Safety Assurance Cases (2010), followed by GessNet’s proposal of TurboAC (2011) and early adoption by infusion pump manufacturers (2012). During this period, GessNet co-designed and instructed major training programs with the FDA and AAMI, and formed pharma partnerships to advance risk management across combination products (PFS, autoinjectors, OBDS, SaMD).
STAGE 2
Expansion & Innovation (2017-2022)
The company continued its growth in adoption and credibility, expanding TurboAC applications to software and cybersecurity projects. QMSpace launched in 2020, evolving from TurboAC to become a comprehensive digital platform for design controls, risk management, cybersecurity, assurance case management, and quality by design. Industry trust grew through real-world use in FDA submissions and inspections, alongside adoption by 25+ companies.
STAGE 3
Next Generation Growth & Industry Partnership (2023 to Present)
The company continued to positioned itself as a leader in in the life sciences industry with expert consulting, advisor, and digital services across design controls, risk management, cybersecurity, assurance case management, and quality by design. QMSpace launched commercially in 2023 with immediate uptake by top pharma companies. By 2024, TurboAC usage grew to +35 companies and QMSpace adoption grew to include selection to support FDA-sponsored Smart and Autonomous Medical Systems (SaAMS) initiatives. In 2025, we filed multiple patents, matured our first-principles approach to safety and effectiveness, rolled out advanced digital-library and platform-lifecycle capabilities, and partnered on global conferences and workshops with professional bodies, industry, and regulatory stakeholders.
