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 [...]

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 [...]

Inaugural Meeting of the Supply Chain Working Group

By |2024-02-06T11:06:35-05:0011/19/2020|

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

Event Recap: Stage-Appropriate Quality Systems

By |2023-06-28T11:34:04-04:0010/22/2020|

Event Recap: Stage-Appropriate Quality Systems Ashutosh Pandit, Consultant & Todd Applebaum, Managing Director Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a [...]

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 [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2023-01-03T16:18:28-05:0008/18/2020|

CMC QA/The Quality System Webinar on 9/30/2020 Essential Characteristics of a Stage-Appropriate Quality System Read the Event Recap 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 challenge is in establishing an appropriate [...]

Why Is Demand & Supply Planning in Life Sciences so Difficult?

By |2021-03-19T12:57:27-04:0007/25/2019|

Event: September 12, 2019 @ 5p Why is Demand & Supply Planning in Life Sciences so Difficult? Demand and Supply Planning is a critical business process for companies moving through clinical development and commercialization. In addition to typical challenges, emerging and growing life science companies face unique obstacles due to clinical, regulatory, [...]

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