Outsourcing: Analysis and developments of contract service providers to the pharmaceutical and biotechnology industries - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Outsourcing
Contract manufacturing organizations (CMOs) and contract research organizations (CROs). Global sourcing of pharma ingredients and services. Trends and challenges for the biopharmaceutical and pharmaceutical industries.

Defining Quality Agreements

August 1, 2013

Pharmaceutical Technology

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.

A Shifting Landscape for the Global API Market

August 1, 2013

Pharmaceutical Technology

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

Optimizing Development, Manufacturing, and Technology Transfer in the Outsourced Relationship

August 1, 2013

Pharmaceutical Technology

Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.

Evaluating China's Supply Chain

August 1, 2013

Pharmaceutical Technology

Increased pharmaceutical trade creates new challenges for regulatory oversight.

Fast Locator: 2013-2014 Europe and Asia

August 1, 2013

Fast Locator: 2013-2014 Europe and Asia

Tracking the Expansion Activities of Contract Service Providers

August 1, 2013

Pharmaceutical Technology

The investment activity of CDMOs and CMOs reveals the broader business and technical trends of the pharmaceutical industry.

Fast Locator 2013-2014 Index

August 1, 2013

View companies' outsourcing profiles from PharmTech's 2013 Outsourcing Resources Fast Locator Index in the following categories.

Fast Locator Index 2013-2014: API Production Technologies

August 1, 2013

Fast Locator Index 2013-2014: API Production Technologies

Stability Reigns in Contract Services

August 1, 2013

Pharmaceutical Technology

The PharmTech/PharmSource annual outsourcing survey results suggest that CDMOs may be getting complacent.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
30%
Breakthrough designations
20%
Protecting the supply chain
50%
Expedited reviews of drug submissions
0%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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