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  • Adapting to FDA Shifts: How to Stay Ahead
  • Navigating the Complexities of Combination Product Regulations and Patents
  • Getting QMSR Ready: Key Changes and Steps to Prepare for the February 2026 Deadline
  • Tips for Hiring Specialty Expertise Consultants
  • Your Guide to the 2024 Combination Products Summit: Agenda, Insights, and What to Anticipate

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When the FDA’s 21CFR Part 4 requirements for combination products went into effect, we needed external support to ensure our design history files were clearly established. We contracted Quality Solutions Now, Inc. who was able to quickly provide us with 4 resources that were experts in design control.
Drug/Biologics Manufacturer Quality Fellow