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 caused by Brexit and is now working its way through yet another challenge: the medical devices...
White Paper: Process Validation and Regulatory Review in the Age of Expedited Approval Drugs Expedited approval drugs have profoundly changed the thinking and approach to Process Validation and other CMC activities. When working on the development of an expedited...
White Paper: Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework Within the cell therapy arena, regulators, the medical community and industry alike are often confronted with an unsettling question. What is this, really? Should a given...
White Paper: mAbs and Their Therapeutic Evolution By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant Monoclonal antibodies (mAbs) elegant specificity has catapulted them to a starring role within the world of precision medicine over the course...
eBook: Key Considerations in Gene Therapy Manufacturing for Commercialization “The regulatory landscape for gene therapies is as transforming as the curative nature of a transgene. In 2012, we saw the introduction of the Breakthrough Therapy Designation. Just when you...
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 promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It...
