From Concept to Compliance: A Practical Stage-Gate Approach that Speeds Global Cosmetic Market Access

April 12, 2026 by Sonal Gadekar

English Cosmetri Webinar with Judith RC Website Featured Image

Bringing cosmetic products to market across the EU, UK, and U.S. has never been more complex—or more critical to get right the first time. Increasing regulatory scrutiny, evolving frameworks, and the need for faster innovation are putting pressure on brands to get compliance right from the very beginning, not as an afterthought. 

In this focused webinar, our expert will introduce a practical stage-gate framework that embeds regulatory compliance into every phase of product development—from concept through launch and beyond. You will gain a clear understanding of how to reduce delays, minimize risk, and accelerate time-to-market by aligning R&D, regulatory, and quality teams within a structured, decision-driven process. 

What We’ll Cover
• How to integrate regulatory compliance early using a stage-gate development approach
• Key checkpoints to prevent delays and costly rework across EU, UK, and U.S. markets
• Strategies to align R&D, regulatory, and quality teams for faster, more efficient launches
• How digital tools like Cosmetri streamline documentation and global compliance workflows
• Practical steps to reduce risk while accelerating innovation and market entry 

Now is the time to rethink how compliance fits into your product development strategy. You will leave the webinar with actionable insights to improve efficiency, strengthen collaboration, and launch products with confidence. We will also leave time for live Q&A with our expert. 

About the Speaker
Judith Fiedler is General Manager of oneRD GmbH and Head of R&D at Steinfels Swiss, with over 20 years of experience across formulation, packaging, and regulatory strategy. She has led global product development at La Prairie and now supports brands in turning regulatory complexity into a driver of innovation, helping bring compliant, market-ready products to market more efficiently. 

   

For Medical Device Establishments, who must register?

Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.

What information is submitted for medical device establishment registration?

In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.

  • U.S. Facilities
    • Initial importers must identify the manufacturers of the devices they are importing.
    • A device must be listed if they fall under the any of the following:
      • Contract Manufacturer
      • Contract Sterilizer
      • Manufacturer
      • Relabeler / Repackager
      • Remanufacturer
      • Reprocessor of Single Use Device
      • Specification Developer
      • U. S. manufacturer of export only devices

       

     

  • Non-U.S. Facilities
    • Must list devices, provide a U.S. Agent, and identify importers.

     

Who must provide medical device listings?

In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.

All facilities that fall under any of the following functions:

  1. Contract Manufacturer
  2. Contract Sterilizer
  3. Foreign Exporter
  4. Manufacturer
  5. Relabeler / Repackager
  6. Remanufacturer
  7. Reprocessor of Single Use Device
  8. Specification Developer
  9. U.S. manufacturer of export only devices

What information is submitted for a medical device listing?

Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.

  1. Company function (activity)
  2. Device product code
  3. Proprietary names
  4. Importer information

What is a master file?

A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.

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