Regulatory support is built into every stage of Gilero’s product development process. Our in-
house team manages submission strategies, interprets evolving guidance, and responds to
feedback across FDA and global regulatory frameworks.
Our Expertise
Regulatory Services
Expert guidance through
every stage of development.
Regulatory Filings & Interactions
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 have extensive experience with 510(k) and De Novo submissions, guiding products efficiently through the FDA clearance process.
We prepare submission-ready materials, including device constituent documentation and relevant eCTD sections for combination products.
Medical Device Development
We help devices obtain regulatory approval faster by creating strong strategies that align development with appropriate regulatory pathways across global markets.
We guide clients through predicate selection and comparison to identify the correct predicate and classification to ensure submission success.
Our team provides expert support in preparing for pre-submission meetings across 510(k), De Novo, and PMA regulatory pathways.
Combination Product Development
We provide comprehensive regulatory and development support for combination products, bridging the gap between device and drug requirements.
Our team has expertise in eCTD submission support and CDER pre-submissions for combination products.
With integrated drug handling capabilities and an ISO 13485 quality system, we help bring combination products to market faster and with confidence.
QUALITY
Our Quality System
Gilero operates under an ISO 13485 certified quality system. Our Quality team ensures our quality management system is compliant with all relevant standards and meets our clients’ requirements.
Talk to an Expert
Ready to take the next step in product development? Connect with the Gilero team to explore tailored solutions—from concept through commercialization.