Converge Perspective on the FDA Delayed Enforcement Originally published on the MassBio News & Thought Leadership blog On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges for implementing the last mile of DSCSA compliance. Chief among these is manufacturers’ inability to [...]
September 14 @ 11a ET | Webinar Digitization of the Supply Planning Process for Growing Biopharma Companies Digital transformation allows companies to reinvent themselves. Organizations can reimagine how work is done and how to create and deliver value to customers. Your company will need to decide when it’s appropriate to embark on [...]
Global Logistics & Trade Compliance Services Info Sheet PDF Available > 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 [...]
ERP Implementations: Understanding Technical Versus Business Go-Live Many life science companies rely on enterprise resource planning (ERP) to help manage and integrate essential parts of the business. Implementing an ERP solution is a major undertaking for any organization. Even when the right ERP option is selected, implementation must consider the needs of [...]
Event Recap: Supply Chain Planning for Today’s Uncertain World Contributors: Supply Chain Director Jeremy Friedler, Supply Chain Consultant Sean Carroll & Intern Ryan Chapados Uncertainty and risk have been consistent themes inherent to biopharmaceutical supply chains. The recent pandemic has only amplified this notion. Since the pandemic started, many emerging companies [...]
DSCSA Implementation & Readiness Efforts for 2023 2023 is a crucial year for pharmaceutical trading partners as the Drug Supply Chain Security Act (DSCSA) deadline for full traceability approaches in November. To allow supply chain stakeholders an opportunity to share their perspectives, the FDA held a 2-day virtual public meeting. DSCSA Implementation [...]
April 6 @ 6-8p Eastern | Boston Marriott Cambridge Traps to Avoid When Preparing for Commercial Launch Preparing for commercial launch is a big deal for most companies. It requires strong leadership and coordination across many functional areas. There are also technical and regulatory hurdles. The company is investing significant efforts and [...]
Commercial Launch Planning on an Accelerated Timeline An emerging European biotech company was preparing to commercially launch its first product in the US. The FDA granted the innovative product a priority review given the potential for significant benefit to patients. As a result, the company faced a compressed timeline to build their [...]
