Aquavit Life Sciences

Where the science is made.

Aquavit Life Sciences comprises two companies, in South Korea and in the United States, providing cGMP manufacturing and research capability to the technologies that carry the Aquavit name.

Built in Korea. Delivered worldwide.

Two companiesSouth Korea and the United States
cGMPFDA-compliant manufacturing
ISO 13485Certified quality system
ISO 5 cleanroomUnder ISO 14644-1
The company

Manufacturing, quality and research in one place.

Controlling the making of a device means controlling its quality, and its pace.

The Aquavit manufacturing presence in Korea was established in 2014 and has since expanded, operating under FDA-compliant cGMP practice within ISO-certified quality systems. A second company operates in the United States.

Manufacturing held close rather than at arm's length does more than raise capacity. It lets drugs, biologics and devices be developed in parallel rather than in sequence.

Since2014
CleanroomISO 5
Quality systemISO 13485
ManufacturingcGMP
cGMP manufacturing
ISO 13485 quality system
CE-marked production
Device assembly
Formulation R&D
Parallel development
Capability

What the Korean operation makes possible.

01

Quality oversight

Direct control of quality assurance and quality control, rather than oversight exercised through a contract manufacturer.

02

Production capacity

Capacity sized for global demand for the device portfolio, with room built in for programs still in development.

03

Compressed timelines

Drugs, biologics and devices developed simultaneously rather than sequentially.

04

Regulatory readiness

FDA-compliant cGMP practice and ISO-certified systems, with CE marking maintained for European market access.

05

Research partnership

Research capability alongside manufacturing, with access to engineering and life-science talent in both regions.

06

Two jurisdictions

Manufacturing and research capability held in more than one country, with the resilience that implies.