ERP Implementations: How to Ensure a Successful Business Go-Live This series starts with ERP Implementations: Understanding Technical Versus Business Go-Live, which focuses on why it is critical to balance the requirements of both for success. Achieving successful go-lives across both the technical and business dimensions is essential to ensuring a successful Enterprise [...]
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 [...]
Event Recap: Avoiding Common Traps in Commercial Launch The commercial launch of a new drug is a make-or-break moment for a company. It represents the culmination of years of R&D, and the potential for significant benefit to patients, as well as financial gain for the company. Emerging pharmaceutical and biotechnology companies often partner [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]