Regulatory Affairs Services

Whether you are in the initial stages of developing a new product, or already have a product on the market, the pivotal role of a robust regulatory team cannot be overstated. Navigating the complex landscape of regulatory requirements is essential for both introducing a new product to the market and ensuring the longevity of products already in circulation. This is precisely where the expertise of ECI comes into play. At ECI, we understand that the regulatory landscape is dynamic and challenging. Our team is committed to being your partner in overcoming these challenges, whether you're at the product development stage or managing an existing product in the market.

For new products in development, our regulatory team is dedicated to facilitating a smooth journey from inception to market entry. We help you streamline the approval process through meticulous planning, strategic navigation of global regulatory pathways, and the preparation and submission of comprehensive documentation to regulatory authorities.

If you already have a product on the market, our regulatory team can help offer strategies to maintain its compliance status. We will work with your cross-functional team to guide you through design and process changes to ensure the best regulatory pathway for your product.

The ECI team brings a wealth of experience, strategic insights, and a proactive approach to regulatory affairs to ensure your products meet regulatory expectations throughout their lifecycle. Contact us to discuss how ECI can ensure your product success story.

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By the Numbers

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Our Capabilities

Regulatory Affairs and Market Access

  • Regulatory Strategy
  • Pre-Market Global Registration Support
    • FDA Q-submission
    • Agency Meeting Representation and Preparation
    • FDA Submission – 513g, 510(k), PMA, De Novo, IDE, NDA, ANDA, BLA
    • CE Mark Certification – EU MDR and EU IVDR
      • Clinical Evaluation Plan and Report (CEP and CER)
      • Clinical Investigational Plan and Report (CIP and CIR)
      • Performance Evaluation Plan and Report (PEP and PER)

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients in need of regulatory services? Find insight into the types of challenges our clients have faced through case studies specific to regulatory affairs.

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Our Strategic Services

Looking for support outside of regulatory affairs? Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Let Us Help

You focus on your business. We focus on the momentum of the industry and help you keep pace across your portfolio.

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