DSCSA Saleable Return Requirements: What the Changes Mean

By |2020-11-20T09:34:26-05:0011/19/2020|

On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies The guidance includes a 3-year delay in enforcing the DSCSA's saleable returns verification requirement for distributors. The enforcement start date is [...]

Inaugural Meeting of the Supply Chain Working Group

By |2020-11-19T11:53:17-05:0011/19/2020|

December 17, 2020 @ 12:00 – 1:00p Register Today Sign up as a member of the Life Sciences Supply Chain Working Group by registering for this inaugural event. The group currently has over 30 members who are supply chain executives at the Director level or above. The meeting program includes: Introduction of Membership [...]

Clinical Supply Management Improved with Single IRT Solution

By |2020-10-30T11:09:36-04:0010/30/2020|

A cancer treatment company with a strong development pipeline had more than a dozen clinical studies in process and that number was growing. A lean team was managing everything and, like many emerging biotech companies, relied on CROs for many clinical operations activities. As those programs progressed through development, our client was dealing [...]

Improving Demand & Supply Planning for Emerging Life Science Companies

By |2020-09-25T09:09:06-04:0009/24/2020|

Improving Demand & Supply Planning for Emerging Life Science Companies Todd Applebaum, Managing Director Our Demand & Supply Planning Maturity Model aligns key aspects of the planning process to each company's lifecycle. Improving demand and supply planning is crucial for Life Science companies. This is especially valuable when dealing with [...]

4 Trends in Commercial Supply Chain Launch

By |2020-09-14T12:03:18-04:0009/14/2020|

Building a commercial supply chain to launch a new product is always a high-wire act. Supply Chain leaders must balance preparing the supply network and launch materials with the uncertainties of clinical development and regulatory progress. In addition, they must manage the risks of commercial uptake and demand. These challenges hold true whether [...]

Clinical Supply Agility: Expect the Unexpected

By |2020-10-20T10:23:00-04:0009/10/2020|

Webinar with 4G Clinical on 10/8/20 Download the Webinar Recording There are constantly unforeseen risks inherent when planning for clinical supply. For instance, when the COVID-19 pandemic began, there was concern that supply chains would be disrupted. Overall supply chains remained operational but questions remained on how to manage [...]

Building the Downstream Commercial Supply Chain for Launch

By |2020-11-10T15:30:01-05:0008/28/2020|

An emerging pharmaceutical company was preparing for its first commercial product launches with two products progressing through the clinic. Approvals and launch events were targeted within one year of each other. The products were similar in technology and formulation. The first anticipated approval was for a relatively smaller indication. The second was for a [...]

New Challenges in Serialization and DSCSA

By |2020-11-09T15:05:53-05:0004/28/2020|

Converge Supply Chain Series webinar on 6/18/20 New Challenges in Serialization & DSCSA Now that federal DSCSA serialization regulations are being enforced for U.S. manufacturers, focus is shifting from first-time implementation to the challenges in serialization execution, management and delivery of business value. Forward-thinking companies are developing strategies for analyzing serialized data to identify [...]

Info Sheet: Serialization Execution

By |2020-11-09T11:35:18-05:0004/01/2020|

PDF Available > After delays in the U.S., federal DSCSA serialization regulations are in effect for manufacturers. EUFMD directives in Europe and other standards around the globe are advancing. The focus of Life Sciences manufacturers is shifting from serialization planning and preparation to serialization execution and management. Serialization is now a standard part of [...]

Info Sheet: Supply Chain Services

By |2020-11-09T11:33:21-05:0001/01/2020|

PDF Available > This info sheet explains our Supply Chain services in more depth.  After all, each stage of a company’s lifecycle has its own set of Supply Chain challenges – regulatory requirements, clinical and commercial uncertainties, logistical constraints and reaching new points of patient care. These all need to be managed while ensuring [...]

Go to Top