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Lachman Consultant Services, Inc. / Articles by: John Darby
10
Jul

ISPE’s Biotech Conference Provides Important Insights

By John Darby    Jul 10, 2023    Biologics Biosimilars BLA Compliance NDA Regulatory Affairs

The ISPE 2023 Biotechnology Conference was held from 26 to 27 June in Dublin, Ireland. Much of the focus of the conference was Cell and Gene Therapy and Advanced Therapy Medicinal Products (ATMPs), terms used in the US and EU for a range of emerging therapies and products in various stages of development. At the […]

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12
Oct

Some Highlights of the October PDA Conference

By John Darby    Oct 12, 2022    Compliance FDA Product quality Regulatory Affairs

The PDA Quality & Regulations Conference was held on October 5 and 6, 2022 in Amsterdam; it was healthily attended by a variety of multi-national pharma manufacturers as well as representatives of regulatory bodies from multiple EU countries as well as the USFDA. The agenda was very much data‑driven as presenters focused on how data […]

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  • About
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    • Medical Device & Combination Products
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    • Regulatory Affairs
  • Services
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    • 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
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