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Featured Product In Drug Books

Accelerating-Generic-Drug-Development

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

$397.00
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval. Read More

Drug Books

Managing Data and Documentation for FDA Inspections

Managing Data and Documentation for FDA Inspections

$397.00
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EU-Compliant Batch

EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU…

$135.00
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IOM-IMAGECOVER

Investigations Operations Manual 2019

$377.00
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Accelerating-Generic-Drug-Development

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

$397.00
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Surviving the New FDA Inspection Plan

Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency

$497.00
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Risk Management in Clinical Trials: The New ICH E6 Focus

Risk Management in Clinical Trials: The New ICH E6 Focus

$397.00
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Data Integrity in the EU: Requirements for Quality Management Systems

Data Integrity in the EU: Requirements for Quality Management Systems

$397.00
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GCP Qualification Audits: Choosing Quality Contractors and Sites

GCP Qualification Audits: Choosing Quality Contractors and Sites

$397.00
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Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors

Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors

$197.00
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

$230.00
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Top Ten Data Integrity Traps: How to Find and Fix Problems

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
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Managing Contract Manufacturers and Testing Labs

Managing Contract Manufacturers and Testing Labs

$397.00
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