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So far Converge Consulting has created 40 blog entries.

Global Trade & Logistics: The Other Side of Compliance

By |2022-08-09T09:12:29-04:0002/22/2021|

An innovative pharmaceutical company was awaiting FDA approval to launch its first commercial product. They were also increasing their clinical trial activities globally and advancing other programs into the clinic. The complexity of their global supply network was increasing. However, they lacked processes, knowledgeable resources, and organizational understanding of global trade compliance requirements [...]

Global Logistics & Trade in a Post-Pandemic World

By |2021-03-26T10:28:46-04:0002/01/2021|

Life Sciences Supply Chain Working Group Webinar on 3/25/21 @ 12-1p Request the Presentation Request the Recording We are seeing new global logistics and trade challenges emerging in our "new normal" business environment, which includes fast-changing trade wars, restrictions on cross-border transport, and huge demands for [...]

Inaugural Meeting of the Supply Chain Working Group

By |2021-03-26T10:56:22-04:0011/19/2020|

December 17, 2020 @ 12:00 – 1:00p Join the Supply Chain Working Group 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 [...]

Ensuring the Path to Compliant Analytical Methods

By |2022-02-08T10:24:24-05:0011/06/2020|

A gene therapy company spent over a decade developing their first-generation product, partnering for many early development capabilities. Then when the product was moving into the final stage clinical development, they bought out the rights and now owned 100% of the molecule. However, with a lean organization who had limited CMC and analytical [...]

Clinical Supply Management Improved with Single IRT Solution

By |2022-02-08T10:25:10-05:0010/30/2020|

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 [...]

Info Sheet: CMC Expertise

By |2021-03-19T11:54:50-04:0009/18/2020|

PDF Available > Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus over time. Companies move from toxicology studies through IND-enabling activities, and from preclinical and clinical testing through commercialization. Tasks and objectives change, but the need for speed, precision, flexible thinking, and [...]

Clinical Supply Agility: Expect the Unexpected

By |2021-03-19T12:55:27-04:0009/10/2020|

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 |2022-02-08T10:26:15-05:0008/28/2020|

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 [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2021-03-19T12:56:03-04:0008/18/2020|

CMC QA/The Quality System Webinar on 9/30/2020 Request the Recording Request the Presentation Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place.  By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The [...]

New Challenges in Serialization and DSCSA

By |2021-04-16T13:14:07-04:0004/28/2020|

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 [...]

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