We help companies embrace the digital thread and leverage technologies to fundamentally improve the way they discover, create, make and sell therapies.

The pace of change in the pharma and biotech industry driven by the COVID-19 pandemic is both exciting and extraordinary.

In a traditionally conservative and highly regulated industry with famously long product development cycles, the pandemic has shown the need for dramatically increasing operational flexibility and reducing time to market.

Companies have been forced to reconsider their processes and broaden their digital capabilities in order to quickly pivot product portfolios, development, manufacturing and campaign fulfillment.

Establishing a digital thread across the drug product value chain creates opportunities for companies to accelerate product development timelines, reduce manufacturing latencies and improve integration with quality and regulatory information management systems. Ultimately, enabling innovators to accelerate speed to market for therapies that improve patient lives around the world.

Our Pharma & Biotech Clients

Small molecule
Biologics
Cell and gene therapy
Generics
Biosimilars
Combination products
In-vitro diagnostics
Nutraceutical, vitamin and nutritional supplements
Contract development and manufacturing organizations (CDMO)

Real Results

CASE STUDY
We helped a leading pharma company speed time to trial and patent approval, scaling their portfolio by over 300% with greater compliance.

CASE STUDY
We helped a leading biologics company reduce batch cycle times by 30%.

Learn More

We drive results for pharma, biotech and CDMO companies across the value chain, from molecule discovery through pharmacovigilance.

Generate Topline Growth

By increasing innovation and accelerating time to market

Drive Bottom Line Improvements

By creating operational efficiencies

Reduce Invested Capital

By leveraging single-use technology

Power the Connected Enterprise

By converging information technology (IT), operational technology (OT), and data science

As strategic partners to some of the largest, most complex pharma, biotech and CDMO companies in the world, we are driven by the core goals of curing conditions, eradicating disease and improving patient lives.

Our work is hands-on, and our knowledge is based on our experience as industry practitioners. We are committed to helping you navigate the industry’s complex regulatory landscape and deliver high-quality medicines to maintain health and enhance patient outcomes.

Case Study / Global Technology, Pharmaceutical and Biotechnology Supplier:

Human-Centered Decision Enablement at Global CDMO

Pharma, Biotech, CDMO Service Focus Areas

Digital Thread Strategy

Transform the way you discover, create, make and sell new therapies with a scalable and actionable plan to digitally connect the enterprise.

Digital Knowledge Management

Improve traceability and enable faster technology transfer and scale up by establishing a single source for materials and process definitions.

Digital Technology Transfer & Scale Up

Accelerate product realization by streamlining the transfer of product and process knowledge between development and internal/external manufacturing, or between manufacturing facilities.

Digital Regulatory Information Management (RIM)

Accelerate the process of bringing compliant products to global markets while adhering to country-specific registration requirements.

Smart Connected Operations

Achieve operational excellence and make better decisions by connecting machines, devices and workers in the enterprise and deriving insights with data science and artificial intelligence.

Extended Reality (AR / MR / VR)

Increase operational efficiencies, productivity, and safety on the manufacturing floor by enabling more efficient learning and remote collaboration.

Technology Partners & Industry Associations

Case Studies

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Case Study / Medical Diagnostics Manufacturer

Case Study / Medical Diagnostics Manufacturer: Improved Quality and Resilient Operations with Advanced, People-Led MES

Fivefold increases in order volumes are now managed efficiently, supporting global demand for diagnostic tools without sacrificing quality
Accurate hang-time monitoring and automated data capture lowered the number of discarded batches, cutting costs and resource usage
Spotless audit record for 13+ years, with full traceability supporting FDA audits across multiple sites
Effective organizational change management encouraged lab technicians, warehouse staff, and quality managers to embrace the MES

Diagnostics Manufacturer Achieves Improved Quality and Resilient Operations with Advanced MES

As global demand surged, a leading biotechnology manufacturer needed to scale the production while maintaining rigorous quality, regulatory, and operational standards. Legacy systems struggled to keep up with the complexity of managing thousands of media recipes—each with stringent storage and time-out-of-refrigeration requirements.

Recognizing that digital transformation would be essential to building a more scalable and resilient operation, the client partnered with Rockwell Automation and Kalypso to implement a tailored Manufacturing Execution System (MES) extending FactoryTalk®PharmaSuite® well beyond its standard capabilities. By focusing on real-time tracking, streamlined workflows and data integrity we helped reduce waste, increase throughput and ensure patient safety across the globe. The resilience of the system and our continued work together has enabled the operation to scale continuously for over a decade, spanning multiple global locations.

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Case Study / Leading Pharmaceutical Company

Case Study / Leading Pharmaceutical Company: Digital Knowledge Management Accelerates Clinical Trials for Leading Pharma Company

Effective collaboration across an extended manufacturing network - Improved knowledge sharing with CDMOs and partners
Streamlined sourcing - Digital repository simplified material and process requirements exchange
Reduced manual effort and risk - Digital transformation replaced paper-based systems
Accelerated speed to clinical trials - Faster development in molecule pipeline
Data-driven decisions - Improved network performance through standardized data structures

Reduced time to clinical trials through streamlined technology transfer and improved CDMO collaboration

We helped a leading pharma company enhance technology transfer and reduce time to clinical trials by implementing digital knowledge management for small and large molecule substances, advanced biologics, targeted drug delivery devices and combination products. Our client had divested their pilot plants and wanted to accelerate getting new compounds ready for clinical trials and commercialization by leveraging CDMOs. They were experiencing knowledge sharing and collaboration challenges due to difficulties in exchanging product requirements and critical formulation data stored in paper-based documents and siloed systems.

We worked with our client through multiple phases, first implementing a digital knowledge management solution for small molecules, creating a unified repository for market requirements, materials, process models, and recipes with clear traceability. We then expanded this capability to their drug delivery devices and combination products business units, tailoring our approach to establish appropriate systems and shifting mindsets to align with leading practices in medical device development. Currently, we're building additional digital mechanisms to further streamline technology transfer, including a technology transfer hub that maps data structures across the extended network and publishes standardized recipes to internal and partner downstream systems.

Background image: Digital knowledge mgmt molecules

Case Study / Leading Biologics Company

Case Study / Leading Biologics Company: Real-Time Analytics Reduces Batch Cycle Times for Biologics Manufacturer

30% reduction in batch cycle times - Faster production through predictive modeling
5% reduction in scrap and waste - More precise process control
Improved product quality - Consistent outcomes from model-based predictions
Real-time decision support - Operators equipped with 95% confidence predictions
Enhanced process control - Continuous monitoring of critical variables

30% reduction in batch cycle times through predictive modeling and machine learning

We helped a leading biologics company reduce batch cycle times by 30%. Our client sought to improve the quality and performance of their production processes with real-time analytics insights. Existing manufacturing processes were based on manual sampling methods resulting in extended batch cycle times and sometimes leading to scrap.

We deployed predictive models that assess real-time independent variables (inlet air temperature, exhaust air temperature, and fan speed) and dependent variables (ideal moisture level) with a machine learning model trained with historical performance data to continuously predict ideal moisture targets with 95% confidence. Operators now have real time decision support model-based predictions for more reliable outcomes with improved batch cycle times.

Thought Leaders

Sachin Misra

Principal & Global Leader - Pharmaceutical, Biotechnology and CDMO Practice

Ryan Fontanesi