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Business Process Improvement (BPI) & Compliance

We have hands-on experience when it comes to supply chain optimization and improving efficiencies across R&D organisations operating in the life science space. Almost 65% of our clients have stated issues with clarity on both API and FP inventory and often find out too late the impact of any audit, non-compliance or tech transfer issues.  
 
Biopharma organizations need to maintain a delicate balance between innovating and delivering patient-centric outcomes while simultaneously dealing with the pressure to minimize cost. TBS can provide novel technology and business solutions to complex operational challenges from clinical operations to streamlining procurement activities, vendor management, and improved supply chain (CMO) collaboration.

Supply Chain Optimization 

  • Project management and governance of rationalization activities to improve the efficiency and reliability of existing supply chains. We have collaborated with partners who use a variety of tools including LEAN and SIX Sigma to map out current processes

  • CMO/CRO vendor audit and selection to understand which partner is most efficient and can optimize your deliverables.

  • Project management and governance of Vendors on interim (ad hoc) basis and review of best practices to improve existing frameworks

  • Engineering & Design: Consulting support in transforming to a “patient-centric” supply chain and providing input on how to design and develop next generation bioprocessing and cell and gene therapy manufacturing sites with reduced operating costs, lower carbon footprints and lower square footage as compared to traditional plants design, i.e., SSU (Modular) vs. Stainless Steel (Stick Build) or a hybrid approach

2

Data Management and Restructuring across Pharma business units (GxP)

  • Review and restructure inefficiencies from operating multiple legacy processes, standards and models across a value chain to help create unified and harmonized “future proofed" data flow across R&D, Clinical, Regulatory, Supply chain and Commercial teams

  • Helping to create “launch excellence” SOPs and P&Ps to create a solid internal foundation of how to bring functional teams together. Our project management methodology is designed to ensure successful on-time launch for pharma products, with clear stakeholder checkpoints and Key Performance Indicators (KPI’s) that track progress and manage risk

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