Flexibility vs. Right-Sizing: Determining the Right Facility Size

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.
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| PEER-REVIEWED RESEARCH |

Statistical Tools to Aid in the Assessment of Critical Process Parameters

The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a critical quality attributes is large enough to make a practically meaningful impact.
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| API SYNTHESIS AND MANUFACTURING |

Polymorph Screening for Identification of Relevant Crystalline Forms

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.
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| TROUBLESHOOTING |

Designing a Biomanufacturing Facility Incorporating Single-Use Technologies

Asking the right questions is crucial to establishing a facility design.
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| SUPPLY CHAIN |

Redefining Pharma Agility

Supply-chain success is measured by how effectively new medications reach patients, and how swiftly manufacturers can react to internal and external changes.
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| OUTSOURCING OUTLOOK |

Pharma Outsourcing Market Expands

The pharma outsourcing market starts 2016 with expansions, acquisitions, and new offerings.
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| REGULATORY WATCH |

Generic-Drug Production and Oversight Challenge FDA and Manufacturers

Policy makers debate strategies for promoting access to less costly medicines.
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Tackling Regulatory Challenges of EU's Variations Framework

The EU is striving to reduce the costs and administrative burden facing pharmaceutical manufacturers when complying with variations regulations for keeping authorization dossiers up to date.
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| VIEWPOINT |

Keynote Series Addresses Crucial Industry Issues

Thought leaders tackle drug shortages and manufacturing innovations.
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| DATA INTEGRITY |

How Important is Data Integrity to Regulatory Bodies?

Data integrity is a widespread, global problem that must be addressed.
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| ASK THE EXPERT |

Phase-Appropriate GMP

Siegfried Schmitt, principal consultant, PAREXEL, discusses the regulatory requirements for CGMPs in the different phases of drug development and manufacture.
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| Webcasts |

Strategies to Accelerate Early Phase Clinical Trials

On Demand
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by SGS

Trends in Quality Agreements & Communications: A CMO Perspective

On Demand
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO­/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.
Sponsored by AMRI