WHITE PAPER The High Bar for Gene Therapy CMC How drug developers can step up to meet regulatory expectations for gene therapy chemistry...
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Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes
WHITE PAPER Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes The European therapeutics market has been working to manage the upheaval...
Process Validation for Expedited Approval Drugs
WHITE PAPER Process Validation and Regulatory Review in the Age of Expedited Approval Drugs This paper explores those dynamics and offers some revised approach suggestions....
mAbs and Their Therapeutic Evolution
WHITE PAPER mAbs and Their Therapeutic Evolution By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant Monoclonal antibodies (mAbs) elegant specificity...
Key Considerations in Gene Therapy Manufacturing for Commercialization
eBook Key Considerations in Gene Therapy Manufacturing for Commercialization “The regulatory landscape for gene therapies is as transforming as the curative nature of a...
4 Things You Need to Know About Combination Drug Compliance
white paper 4 Things You Need to Know About Combination Drug Compliance Combination products are a fascinating area of the pharmaceutical industry and present great future...
