Search Results for 'Supplement'
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APIs | Excipients | Inspections | Laboratory Testing | Supply Chain | Validation
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Process Validation | Validation
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Regulatory Affairs
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APIs | Chemistry | Cleaning Validation | Clinical Trials | Drug Development | Inspections | Process Development | Process Validation | Regulatory Affairs | Toxicology | Validation
On the Fast Track
Project management and FDA interaction when an NDA is Fast TrackedGary A. Baker and Vince Ammoscato 09.04.08
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Clinical Trials | Drug Development | Fill/Finish | Lyophilization | Parenterals | Vials
Outsourcing Cytotoxics & Highly Potent Parenterals
The economics of choosing a CMO are changingBurkhard Wichert, M.D. 09.04.08
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Drug Development
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Drug Development | Regulatory Affairs
Clinical Research Outsourcing
Moving from transactional to strategic partnership-based outsourcingKenneth Getz and Rachael Zuckerman 05.30.08
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Drug Development | Logistics | Preclinical Outsourcing | Toxicology
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FDA Proposes Change To CBE Supplement Rule
Proposed rule to codify long-standing policy stirs debateGary C. Messplay, J.D. 04.30.08
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Clinical Trials | Drug Development | Drug Discovery | R&D
Opportunities Beyond Cost Savings
Maximizing the Strategic Value of Global R&D OutsourcingPartha Ghosh and Kimberlee Luce 01.17.08
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Clinical Trials | Drug Development | Drug Discovery | Logistics | Supply Chain | Validation
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Inspections | Validation
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Follow-Up with Follow-On Biologics
Breaking down the new biogenerics billGary C. Messplay, J.D. 04.02.07
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Information Technology | Supply Chain
Pharma IT Hiring Trends
Pharma hiring managers find tech talent in high demandJim Lanzalotto 03.02.07
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Chemistry | Drug Development | Financial Reports
Consolidation in Outsourcing
Our annual report chronicling the M&A activity in the outsourcing sector in 2006Michael Martorelli 01.26.07
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APIs | Drug Delivery | Drug Development | Excipients | Supply Chain | Validation
Excipient Quality in Pharmaceutical Development
Understanding their functions benefits process controlLokesh Bhattacharyya, Ph.D. 06.08.06
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Chemistry | Clinical Trials | Drug Development | Drug Discovery
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cGMP Manufacture | Cleaning Validation | Process Development | Validation
Disposable Bioprocessing
The impact of disposable bioreactors on the CMO industrySandra Fox 08.23.05
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Capsules | Chemistry | Drug Development | Logistics | Lyophilization | Supply Chain
The Importance of Supplier Management
A sponsor's perspective on achieving operational successHany Salama, ME 08.23.05
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Clinical Trials | Drug Development | Regulatory Affairs
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APIs | Chemistry | Drug Delivery | Drug Development | Drug Discovery | Supply Chain
Drug Delivery Outsourcing
Considerations when outsourcing drug delivery systemsMichael J. Valazza, Cornell Stamoran 08.22.05
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Capsules | Chemistry | Excipients | Laboratory Testing | Reader Showcase | Validation
2nd Annual Contract Pharma/ Nutraceuticals World Supplement
Contract Pharma and Nutraceuticals World offer a supplemental issue with articles on Raw Materials Methodology Transfer and Ventilation Enclosures for Dust Containment, as well as an extended Reader Showcase sectionJames Neal Kababick 08.22.05
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Chemistry | Cleaning Validation | Process Development | Process Validation | Validation
Management Practices for API Manufacturing
Specification development and selectionCliff R. King, Ph.D. 08.22.05
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Validation
Conducting an Effective cGMP and Quality Systems Audit
A sponsor's guide to the audit processShamik Pandit and Marcia Gartzke 08.22.05
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Bioassay Development | Capsules | Clinical Trials | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Methods Development | Preclinical Outsourcing | Process Development | Toxicology
eBusiness Communities
Building business through the internet creates an alternative to one-stop shopping.Rhonda Shrader 08.22.05
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Analytical Services | Bioanalytical Services | Bioassay Development | Capsules | Chemistry | Clinical Trials | Drug Development | Excipients | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Inspections | Lyophilization | Methods Development | Preclinical Outsourcing | Process Development | Process Validation | R&D | Regulatory Affairs | Solid Dosage/Semi-solids | Supply Chain | Toxicology | Validation
Outsourcing Natural Product Services
A look at key components for outsourcing services for natural product R&D and manufacturing.John B. Awater, Ph.D. 08.22.05
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Analytical Services | APIs | Bioanalytical Services | Bioassay Development | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Inspections | Lyophilization | Preclinical Outsourcing | Process Development | Process Validation | Regulatory Affairs | Toxicology | Validation
Pre-Approval Inspection of a Contract Manufacturing Facility
Outsourcing offers companies a new option in this regulatory process.Dilip M. Parikh 08.22.05
