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American Pharma Manufacturing & Outsourcing Summit

Network with over 150 pharma leaders and explore strategies to maximize efficiency while remaining compliant.

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Event

American Pharma Manufacturing & Outsourcing Summit

Network with over 150 pharma leaders and explore strategies to maximize efficiency while remaining compliant.

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Pharmaceutical
11/15/2024 18:07
Event
Event

Insights from an FDA Expert: Adapting to the New Laboratory Developed Test Regulations

If you missed our recent event, you can still access valuable insights from Sonia Lecce, Senior Regulatory Consultant, on the FDA's new LDT (Laboratory Developed Test) ruling.

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Research & Development
Regulatory Compliance
Medical Devices
11/15/2024 18:04
Event
Event

Best Practices in Successful Product Design Acquisition Integration

Orla Blount, Sr. Director of Business Development, Shital Patel, Chief Operating Officer & Sr. VP of Operations, and Maylin Truesdell, Director of Regulatory Affairs, of ECI led a plenary session at the AMD Summit 2024 on the value of pre-acquisition due diligence and post-acquisition gap assessments. Access the full recording here.

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Mergers & Acquisitions Support
Medical Devices
11/15/2024 18:03
Event
Case Study

Regulatory Submission Review

Discover how ECI’s expert team navigated regulatory complexities to expedite product approvals in our latest case study. Learn about the tailored strategies and impactful solutions we implemented to streamline compliance and support our client’s success. Read more to see how we can help you achieve regulatory milestones efficiently.

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Regulatory Compliance
Medical Devices
11/15/2024 17:40
Case Study
Case Study

Regulatory Support to New Product Development Project

ECI assisted a medical device firm in developing a cloud platform for remote patient care, covering data flow, regulatory strategy, and FDA pre-submission. ECI ensured compliance with FDA and NIST standards and provided essential documentation for the client's digital health solutions.

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Regulatory Compliance
Medical Devices
11/15/2024 17:40
Case Study
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