Benefits of Using Foreign Trade Zones for Emerging Biotech Companies

By |2021-12-07T11:14:42-05:0012/07/2021|

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D, paying duty on each import can significantly impact cashflow, sometimes measuring in the hundreds of thousands of dollars. This impact is amplified [...]

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022

By |2021-12-07T12:19:34-05:0011/16/2021|

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

By |2021-11-16T08:50:29-05:0011/16/2021|

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]

Info Sheet: Clinical Supply Chain Services

By |2022-08-05T10:56:29-04:0011/09/2021|

PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

By |2021-11-08T17:08:01-05:0011/08/2021|

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]

Info Sheet: Serialization Execution

By |2021-11-08T14:36:46-05:0011/08/2021|

PDF Available > DSCSA serialization regulations in the U.S. and EUFMD directives in Europe are now being enforced for manufacturers. Other standards around the globe are also advancing. The focus of Life Sciences manufacturers is shifting from serialization planning and preparation to execution, management, and business value. With manufacturer requirements in place, serialization is [...]

Personal Information Protection: Broader than You Think

By |2021-11-02T10:12:07-04:0011/02/2021|

National and state governments are enacting laws to protect personal identifiable information (PII) from use without data subjects’ consent. Additionally, federal regulations are now in place to safeguard protected health information (PHI). A few examples of such laws active today are the General Data Protection Regulation by the European Union, the California Consumer Privacy [...]

Building High-Touch Patient Supply Chains

By |2021-11-16T16:24:09-05:0010/14/2021|

Life Sciences Supply Chain Working Group Webinar on 11/16 @ 12-1p ET REQUEST THE PRESENTATION REQUEST FOR RECORDING This event will provide insights on emerging methods and practices for designing supply chains focused on building and maintaining close relationships with physicians and patients. Supply Chain Working [...]

Biopharmaceutical Supplier Risk Management: What You Need to Know Now

By |2021-10-13T11:12:51-04:0010/13/2021|

The COVID-19 pandemic exposed the risks and fragility inherent in global pharmaceutical and biotechnology supply chains. This isn’t really news though. For some time, these supply chains have lagged other industries in speed, flexibility, agility, redundancy, and diversification. With risk considerations at the forefront resulting from shortages during the pandemic, the US government is [...]

Global Trade Compliance: Why Emerging Biopharmaceutical Company Operations Executives Need to Take Notice

By |2021-09-30T13:18:28-04:0009/27/2021|

Today’s biopharmaceutical supply chains often stretch around the world. Key starting materials (KSM) and API originate more frequently from Asia. Manufacturing is commonly conducted in Europe and North America. And commercial distribution is spread across the globe. This globalization has resulted in increased logistics and global trade compliance (GTC) complexity along with ever-changing import/export [...]

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