OUR PLATFORM

Discover all your knowledge can do

Start with the software that brings digital chemistry, manufacturing, and controls (CMC) to pharma and biotech for the first time.

Digital CMC for drug products

In an industry full of retrofit software solutions, QbDVision is a purebred platform for pharma and biotech – – purpose-built to deliver the solutions that matter most for teams like yours.

Organize

your unstructured knowledge and data

Automate

repetitive tasks and complex workflows

Collaborate

across teams and functions

See

exactly how your projects and risks are evolving

Secure

your data and ensure it’s regulator-ready

Speed Up

development of new breakthrough therapies

OUR FOCUS

Solving a legacy challenge

challenge
solution

Today, lack of structure slows development

Our industry still leaves its knowledge and data scattered across inboxes, folders, spreadsheets, PDFs, and legacy QMS. The result: inefficient processes, poor process understanding, product quality risks, and product life cycles delayed by information barriers.

Our structured platform brings it all together

QbDVision provides a unified framework that connects it all — your information, your processes, and your people — in ways that help teams turn science into products with unprecedented efficiency, coordination, and agility.

WHAT YOU GET

One software with all the tools you need

With QbDVision, they can manage everything from a single login — process evolution, risk evaluation, and data analytics — without the inefficiency and data integrity risks of disconnected, legacy software solutions that create barriers to shared knowledge.

WHAT YOU GET

One software with all the tools you need

With QbDVision, they can manage everything from a single login — process evolution, risk evaluation, and data analytics — without the inefficiency and data integrity risks of disconnected, legacy software solutions that create barriers to shared knowledge.

WHAT QbDVISION CREATES

A foundation for simpler workflows and smarter decisions

With all your knowledge, data, and systems in one place, you can finally sync up all the workflows that depend on those resources. And with all those activities in sync, it’s easy to see how you can optimize every one of them.

SOLVE FRAGMENTATION 1

Solve fragmentation

Unite siloed workflows, reveal implicit knowledge, and collect scattered data.

CONSOLIDATE INFORMATION

Consolidate information

Create a shared, centralized knowledge base with a structured framework.

ENHANCE COORDINATION

Enhance coordination

Make it easy for your teams to work together, align approaches, and transfer knowledge.

CREATE INTELLIGENCE

Create intelligence

Make every decision based on contextual guidance and visualized insights.

WHAT IT DELIVERS

A modern digital path to efficient, agile CMC

As your product and processes evolve in QbDVision, so do your understanding and control. Using our platform ensures you always have a holistic, historical view of the entire life cycle — so you can always make the best decision at exactly the right time.

PLATFORM_PATH_STACK_SHORT

KEY FEATURES

Benefits of a structured platform

FAST DEPLOYMENT
BUILT-IN COMPLIANCE
ROBUST SECURITY

Fast deployment

Your teams can be up and running on our cloud-based software in minutes. With our intuitive user interfaces, inline documentation, and world-class customer support, your teams can bring down data silos and start building a shared knowledge base in a few clicks.

Built-in compliance

Every click in QbDVision facilitates compliance with ICH and ISO quality guidelines, 21 CFR 11, and EU Annex 11 data integrity requirements. Users and regulators can easily access the complete, accurate, and fully contextualized information they need at every step of the product life cycle.

Robust security

QbDVision protects your proprietary data with best-in-class security features built on AWS. Activity logging, version control, and audit trail capabilities ensure that input information can be tracked and archived but never deleted — guaranteeing a complete, secure record of all the data we manage.

GO DEEPER

See everything our platform makes possible

KNOW WHERE

Centralized knowledge management

Collect all your teams’ data and knowledge in one searchable, cloud-based hub.

KNOW HOW

Streamlined process development

Create robust, agile processes that your teams can control as one.

KNOW WHY

Powerful process intelligence

See what every action means for the whole product life cycle.

Try QbDVision today

Test drive our software’s core functionality or book a full platform demo.

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Life Sciences Luminary and Influencer

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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Speaker’s Pretty Long Title, Specialty, and Business

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