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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

The Road to a Pharmaceutical Quality System in the EU

The Road to a Pharmaceutical Quality System in the EU

$100.00
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The Revised ICH E8: A Guide to New Clinical Trial Requirements

The Revised ICH E8: A Guide to New Clinical Trial Requirements

$397.00
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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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