Biopharmaceuticals

Is Everyone On The Same Page?

Achieving quality and compliance in your drug and biologics development programs isn't as easy as it sounds. In fact, without the right quality system in place, you could be creating costly and time-consuming obstacles for yourself further down the development pathway or derailing your program altogether. Quality and compliance requirements touch every part of your development programs from preclinical through to commercialization and yet, the sheer number of FDA warning letters and consent decrees demonstrates that this is a significant and continuing problem in the industry. To mitigate risk, you need to have the quality and management experience on your team to ensure that systems are in place to effectively monitor the state of control. This oversight ensures that you manage risk appropriately, achieve your development goals and avoid any nasty surprises in the future. And if there are any surprises, you can rely on experienced NovusLife consultants to help you remediate the issues and respond appropriately.

Specific Services

Document Drug Master File
GLP/GCP Auditing
CMC Review
Batch Record Review
Investigate Out of Tolerance Events
Process Control, Validation and Monitoring
Test Method Validation
Establish In-Process Environmental Monitoring Programs
Stability Testing and Expiration Dating Protocols/Reports
Failure Investigation and Resolution
Complete Data Monitoring Committee (DMC) Management
Scientific and Medical Writing Services

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