Government Consulting

Pharmaceutical Industry Consulting

Pharmaceutical Industry Consulting

Government Consulting

New At Shabas

April, 2025

FDA CDER is inviting qualified pharma companies to participate in the next round of Quality Management Maturity (QMM) protocol assessment.

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May 28, 2024

Approaches for Use of Digital Health Technologies in Clinical Trials

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August 6, 2024

Podcast: Expanding the Use of Digital Health Technologies in Clinical Trials Monitoring

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July 1, 2024

In Regulatory Focus: The FDA’s Quality Management by Robert Michalik, JD, RAC, and William Hauck, MSc

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May 28, 2024

Development of Next-Generation COVID-19 Vaccines: BARDA Supported Phase 2b Study Designs

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August 7, 2023

Indian government sets deadline for Pharma GMP Compliance

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August 9, 2023

QMM Podcast 1

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May 1, 2023

QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract Manufacturers

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December 30, 2022

Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

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December 29, 2022

FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

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