We help pharmaceutical companies develop reliable drug delivery devices.
Most pharma companies focus on drugs, not devices.
At Archimedic, we provide drug delivery expertise and an ISO 13485 certified QMS to help pharma companies transform drugs and biologics into reliable combination products.
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What's the pathway to a successful drug delivery device?
STEP 1
Requirements Definition
Define drug-device compatibilities, user requirements, regulatory requirements, and the detailed plan to achieve program objectives.
STEP 2
Concept Design
Design and evaluate the device architecture, user interfaces, regulatory pathway, and system functionality needed to achieve the defined requirements.
STEP 3
Detailed Development
Implement design control, conduct risk analyses, test prototypes, engage key suppliers, and conduct design for manufacturability and assembly.
STEP 4
Verification & Validation
Manufacture controlled units and conduct inspections, performance testing, drug-device compatibility, sterilization testing, and clinical testing.
STEP 5
Manufacturing Transfer
Prepare all design files, work instructions, packaging / labeling specifications, and quality documentation for a seamless transfer to CMO.
Need help driving the process?
> Book Strategy CallJOIN WEBINAR ON 11/15/2023 AT 11AM EASTERN
[Webinar] How to accelerate timeline and reduce risk in combination product development.
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Tune into this focused webinar to learn about the common mistakes made by drug delivery developers that cause major timeline slippages and quality issues.
This webinar will be presented by Eric Sugalski, Founder and CEO of Archimedic.
Eric will share actionable tips on how to accelerate your timeline and reduce risk in drug delivery development programs.
Webinar duration: 25 minutes
Date: November 15, 2023
Time: 11AM Eastern
> Register for WebinarWhat do our clients say?
What does success look like for you? Here's what we aim to achieve in your drug delivery device project.
