Industries
Medical Devices
We deliver end-to-end Regulatory and Quality solutions that empower medical device manufacturers to achieve, maintain, and demonstrate compliance with global regulations and standards across the USA, Europe, LATAM, CEMA, and ASEAN regions.
Our services include comprehensive assessments of global market strategies, regulatory requirements, and submission pathways to support successful product approvals.
In-Vitro Diagnostics
We provide comprehensive Regulatory and Quality solutions tailored for In Vitro Diagnostic (IVD) products, empowering manufacturers to achieve, maintain, and demonstrate compliance with global regulatory frameworks — including those of the USA, Europe, LATAM, CEMA, and ASEAN — and internationally recognized standards such as ISO 13485 and IVDR.
By simplifying complex regulatory pathways and embedding quality excellence throughout the development process, we accelerate market access, ensure continuous compliance, and help deliver accurate, reliable, and high-performing diagnostic solutions to healthcare professionals and patients worldwide.
Medicinal Products
We provide end-to-end regulatory support for pharmaceutical products, ensuring compliance with global health authority requirements including FDA, EMA, WHO, and other regional agencies. Our services cover dossier preparation (CTD/eCTD), product registration, variations, renewals, and regulatory strategy — enabling faster approvals and sustained market access across multiple regions.