Enabling your advanced therapies operations.  

We provide specialised consultancy services across strategy, tactics, and execution to optimise and evolve your operational processes. From early clinical stages to global commercial models, we unlock the full value chain of your operations.

Planning and Strategy

Supply Strategy and Integrated Business Planning (IBP)
Developing tailored supply strategies, combining operational and financial planning to align resources ,reconcile demand with supply and meet operational business goals ,whilst controlling cost.

Long-Term Manufacturing Scale-Up
Design and create long-term manufacturing capabilities road-maps that meet demand at the right time, the right size, with deployment plans that translate strategy into execution.

Point of Care and Hybrid Manufacturing
Strategic and tactical advisory for long term manufacturing network planning: centralised, de-centralised, hybrid.

Commercial Operations and Market Access 
Advisory for commercial operations and market expansion as it pertains to operational matters such as distribution strategy and operational planning for launch readiness.

Key Raw Materials Strategic Sourcing and Supplier Onboarding
Securing reliable raw material suppliers for DNA, Viruses and other modalities and managing onboarding processes such as service agreements, statement of work and quality agreements to ensure consistency, compliance and reliability. Support for defining the raw materials strategy for testing as part of manufacturing readiness as it pertains to regulatory guidelines. 

Supply and Manufacturing Operations

Supplier Selection and B2B opportunities
Conduct research, benchmark and indentify relevant B2B partnerships. Our network helps bridge the gap between cutting-edge technology providers and biotech firms, fostering strategic alliances that accelerate development and approval pathways.

CDMO Master Service and Supply Agreements
Assisting with the negotiation and lifecycle management of CDMO/CMO service and supply agreements as per current and future needs for products and services.

Demand and Supply Planning
Design and roll out of mature supply planning processes tailored to advanced therapies that align demand with manufacturing capacity and integrates first and second tier suppliers.

GMP Manufacturing Planning and Scheduling
Design and management of GMP-compliant manufacturing schedules and manufacturing readiness operational processes that meet regulatory standards and ensure timely production, in full and of expected quality. 

Commercial Supply Chain Operations
Design and management of commercial supply chains, ensuring scalability and cost-efficiency as therapies move to multiple geographies and delivery modalities. 

Supply Chain as a Service
Providing end-to-end supply chain management services, tailored to the unique needs of emerging therapies to include training programs for relevant skills and capabilities, supply chain leadership development and interim executive temporary assignments.

Clinical Trials Operations

Early Stage 
Design and optimisation for clinical trial strategies and laboratory setup.

Data Integrity and Compliance  
Good Clinical Laboratory Practice (GCLP) leadership and advisory for high-quality clinical data generation and rigorous compliance oversight .

Late stage and Operational Management
Project support and oversight of late stage operational lifecycle for clinical trials, focused on CRO selection, resource allocation,manufacturing planning and logistics.

Patient-Centric Services

Patient Journey Process Design and Roll-Out
Design and setup of patient-centric workflows to streamline therapy delivery, ensuring efficient Vein-to-Vein timelines from start to finish and external manufacturing integration.

Distribution and Logistics
Design and initial setup of distribution models. Supplier selection and distribution agreements, ensuring the safe and timely delivery of therapies globally.

Qualified Treatment Centres Supply Agreements
Establishing and managing supply agreements with qualified treatment centres to ensure compliance and seamless therapy administration.

Qualified Treatment Centres Integration
Integrating qualified treatment centres into your supply chain ecosystem and cross-functional planning processes is vital to ensure efficient therapy delivery, fully aligned with medical and regulatory guidelines.

VC | Mergers and Acquisitions Services

Venture Capital and M&A Due Diligence Advisory 
Providing expert support during due diligence and hands-on management as part of VC investements and M&A, focusing on supply chain risk, network planning, inventory transactions and data migration.

Program Acquisition and Program Divestment Project Management
Managing the acquisition or divestment of programs with a focus on smooth transitions, operational continuity or termination of assets.

Technology and Integration

SaaS-Based Control Tower Systems
Design, development and implementation of SaaS-based operational planning systems that provide visibility and control across the operational value chain, from pipeline management, supply planning , KPI's and cost analysis. 

ERP Implementation and IoT Integration
Facilitating the implementation of ERP systems and IoT solutions that support scale up and enhance operational transactional efficiency and data-driven decision-making.

Digital Orchestration Platforms Support
Supplier selection advisory and implementation support for platforms that can digitise the entire patient journey.

Data Analytics and AI Powered Software Development
SME and Business Analysis advisory for design ,development and deployment of data analytics strategies and data analytics apps. Co-development of proprietary ML and AI powered solutions that can adress the operational value chain.