Regulatory support is built into every stage of Sanner’s product development process. Our in-house team manages submission strategies, interprets evolving guidance, and responds to feedback across FDA and global regulatory frameworks.
With expertise in medical devices and combination products, we streamline regulatory planning, filings, and agency interactions to accelerate timelines, ensure compliance, and support a smooth transition to commercial production.
We help devices reach regulatory approval faster with strategies that align development to the right regulatory pathways across global markets, including predicate selection and classification guidance for submission success.
Sanner operates under an ISO 13485 certified quality system, with sites that are FDA-registered and cGMP-compliant. Our QMS supports combination products under FDA 21 CFR Part 4, integrating 21 CFR Parts 820 (QMSR) and 211, alongside EU MDR (2017/745) and NMPA (National Medical Products Administration) compliance.
Accelerating the time to market for a novel ophthalmic implant drug.
Developing a closed system transfer device that protects clinicians from hazardous drugs without slowing them down.
End-to-end development and manufacturing for an innovative IV bag.
Stay current on regulatory trends, guidance updates, and lessons from the field, straight from Sanner’s regulatory and quality teams.
