Info Sheet: Global Logistics & Trade Compliance Services

By |2024-02-06T14:50:52-05:0005/23/2023|

Global Logistics & Trade Compliance Services Info Sheet Download PDF Supply chains are growing in complexity whether they support preclinical, clinical, or commercial companies. Biopharma companies work with a global network of suppliers, labs, and contractors, all while the industry continues experiencing after-effects of pandemic-related restrictions and disruptions. The need to manage [...]

Info Sheet: Extending Your Quality Capabilities

By |2024-02-06T15:00:21-05:0008/18/2022|

Extending Your Quality Capabilities Info Sheet Download PDF Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced [...]

Info Sheet: Clinical Supply Chain Services

By |2024-02-06T15:13:07-05:0011/09/2021|

Clinical Supply Chain Services Info Sheet Download PDF 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 [...]

Info Sheet: Serialization Execution

By |2024-06-19T21:39:49-04:0011/08/2021|

Serialization: Value Beyond Compliance Info Sheet Download PDF After years of phased implementation and a stabilization period, the FDA is poised to begin enforcement of federal DSCSA serialization regulations across the end-to-end pharmaceutical supply chain. EUFMD directives in Europe are also in place with other standards around the globe advancing too. The [...]

Info Sheet: IT Roadmaps for Commercial Launch

By |2024-02-06T14:58:23-05:0004/08/2021|

IT Roadmaps for Commercial Launch Info Sheet Download PDF After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for their first commercial launch. As this organizational transformation nears, the focus of the IT organization shifts from infrastructure and help desk support [...]

Info Sheet: Scaling & Sustaining Commercial Growth

By |2024-02-06T14:55:48-05:0003/18/2021|

Scaling & Sustaining Commercial Growth Info Sheet Download PDF As life science companies advance beyond the first launch of commercial products, strategic focus shifts. Attention moves to expanding the business, regulatory and geographic reach of their treatments. Market expansion, label expansion, and further pipeline development create more opportunities. Companies pursue these efforts [...]

Info Sheet: Cell & Gene Therapy Services

By |2024-02-06T15:15:46-05:0003/02/2021|

Cell & Gene Therapy Services Info Sheet Download PDF Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and [...]

Info Sheet: CMC Expertise

By |2024-02-06T15:11:57-05:0009/18/2020|

CMC Expertise Info Sheet Download PDF 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 [...]

Info Sheet: Enterprise IT Strategies for Life Science

By |2024-02-06T15:03:04-05:0001/01/2020|

Enterprise IT Strategies for Life Science Info Sheet Download PDF Managing enterprise information technology in emerging and growing Life Science companies is challenging beyond the typical IT dilemma. This info sheet explains how Converge develops Enterprise IT strategies in life science. Emerging biopharma companies work with limited resources, scientific and regulatory uncertainties, [...]

Info Sheet: Operational Excellence Services

By |2024-02-06T14:57:03-05:0001/01/2020|

Operational Excellence Services Info Sheet Download PDF Biopharmaceutical firms face huge challenges as they commercialize their drug discoveries. This info sheet explains Converge Consulting's Operational Excellence services that help mature companies optimize their processes at both the large and small scale. The level of internal risk is high given daunting technical challenges [...]

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