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NDSRIs

Lachman Consultant Services, Inc. / Blog / NDSRIs
11
Aug

NDSRIs – Alignment At Last (Sort Of) 

By Jennifer Leaming    Aug 11, 2023    ANDAs Compliance FDA NDA NDSRIs Nitrosamines OTC

The industry as a whole rejoiced on Friday with the publication of the new NDSRI guidance from the FDA, previously discussed here.  Now that we all have had more time to carefully read and absorb the details posted by the FDA in the guidance and on the corresponding webpage, many will discover that there are […]

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  • About
    ▼
    • Lachman Leadership Team
    • Lachman Board of Directors
  • Areas Served
    ▼
    • Pharmaceutical
    • Medical Device & Combination Products
    • Biologics
    • Regulatory Affairs
  • Services
    ▼
    • FDA-Related Services
    • Compliance
    • FDA 483 Response
    • Data Integrity
    • Mock FDA Inspections
    • Analytical Services
    • Biomonitoring Support
    • Strategic Planning
    • Due Diligence Audits
    • Quality Assurance and Controls
    • Scientific and Technical Assistance
    • Systems Evaluation
    • Facilities Design or Validation
    • System Process Validation or Qualification
    • Training
    • Remote Services From Lachman
  • Markets
    ▼
    • Pharmaceuticals
    • Medical Devices
    • Combination Products
    • Biotechnology
    • Biologics
    • Diagnostics
    • Generics & Biosimilars
    • Related Industries
  • Blog
  • News
  • Contact
  • Careers
    ▼
    • Career Opportunities
  • Resources
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    • Lachman Learning
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