Navigating Stage-Appropriate Quality System Design

By |2024-02-06T14:06:00-05:0006/29/2023|

Navigating Stage-Appropriate Quality System Design Originally Published as a MassBio Guest Blog Our emerging biotech and biopharma clients often request support from our skilled consultants and practitioners to develop a “Stage-Appropriate cGMP Quality System." However, we find that they are often not fully aware of what “stage-appropriate” means or what it looks [...]

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 [...]

Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs

By |2023-07-07T11:38:00-04:0002/28/2023|

Event Recap: What CMC & Finance Leaders Need to Know about Maintaining Alignment on CMC Programs CMC and Finance in emerging biotech companies are important partners, but they often find themselves at odds with one another. Complex CMC programs are dynamic, often changing substantially, and require large investments. Similarly, the financing environment in [...]

Minimizing COI & COC Risk

By |2023-02-07T13:24:28-05:0002/07/2023|

Minimizing COI & COC Risk 3 Essential Components for Autologous Cell Therapy Facilities Originally Published as a MassBio Guest Blog Autologous cell therapies involve collecting and processing a patient’s own cells, and later administering the processed cells back into the body to treat the same patient. The personalized nature of these [...]

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 [...]

Transitioning to Computer Software Assurance from Computer Systems Validation

By |2023-03-16T10:27:15-04:0003/29/2022|

Transitioning to Computer Software Assurance from Computer Systems Validation Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional approach for meeting this requirement is computer system validation (CSV). CSV emerged decades ago when computer systems were less reliable, and software was [...]

CMC Project Plans: A Critical Tool for Early-Stage Biopharma

By |2022-01-25T10:42:30-05:0001/25/2022|

CMC Project Plans: A Critical Tool for Early-Stage Biopharma The Challenge for CMC Teams CMC activities are critical to early-stage biopharma companies preparing for commercialization. Growth of the company depends on the CMC team achieving milestones, which are technical and cross-functional. They also typically require capital investments. CMC teams operate in [...]

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 [...]

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