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Quality & Regulatory
Resyca is committed to complying with applicable legal and regulatory requirements, standards, and internationally recognised best practices.

We aim to meet the high expectations of our pharmaceutical partners regarding the quality, safety, and efficacy of our nasal delivery and inhalation devices, as well as all related services.

Certified Quality Systems
  • ISO 13485
    Resyca has maintained ISO 13485 certification since 2022, demonstrating our commitment to quality management systems tailored for medical devices.
  • Medical Device Regulation (MDR)
    Our operations are fully aligned with Regulation (EU) 2017/745, ensuring compliance with the latest European standards for medical device safety and performance.
  • FDA Quality Systems Regulations (QSR)
    Resyca’s quality management system adheres to the requirements of 21 CFR Part 820, supporting regulatory compliance for drug-device combination products in the United States.
Regulatory Strategy & Global Compliance

Resyca supports regulatory submissions across Europe and the United States, including Drug Master File (DMF) preparation and Design History File (DHF) documentation for nasal spray and soft mist inhaler platforms.

We support our partners in clinical trials under EU Regulation 536/2014 and FDA requirements, and in communication with regulatory authorities such as the EMA, FDA, and national competent authorities.

Resyca ISO 13485 certificate
Resyca Medical Device Regulation MDR (EU) certificate
Your Breakthrough. Our Capabilities. Ready When You Are.
Resyca is here to support your journey.

Let’s shape the future of soft mist inhalation together.

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