DIGITAL CMC SOLUTIONS

Streamline your tech transfers

Discover how QbDVision turns one of your biggest operational bottlenecks into an efficient, modern digital workflow.

Today’s tech transfers are slow, expensive, and document-dependent

Exchanging knowledge and data is the crux of this critical process. But all too often, those vital resources are locked in PDFs, buried in inboxes, or stacked in folders and SharePoints.


Manually gathering, sifting, and sharing documents is a time-consuming, costly process that bottlenecks development – and not just once, but many times in your product’s life cycle. It’s time for a better way to transfer.

24-30 Months

on average to complete a tech transfer

$38-389MM

in personnel costs alone for a typical 28-month tech transfer

80%

of scientists’ time is spent sourcing and consolidating information

We turn documents into usable, sharable, real-time process data

Never chase another file or get lost in another SharePoint. QbDVision is the source for all your CMC resources – QTPPs, CQAs, CPPs, analytical methods, change control logs, and more – your organization’s data is unlocked, connected, and accessible to your entire transfer team.

It’s all there for everyone, in an insight-rich process hub that makes tech transfers faster and more efficient than ever.

With fast, efficient data exchange, everybody wins

Make sharing knowledge as simple as logging in

QbDVision unites your process knowledge, data, and specs in one shared, holistic view. No pulling files, finding attachments, or triplicate updates. Just smarter planning, faster problem-solving, and quicker execution.

Verify transfer readiness

With one comprehensive view of your processes, materials, equipment, and more, you can assess your transfer readiness in clicks – not months.

Instantly analyze gaps & risks

Compare parameters, protocols, and methods at a glance – site by site, element by element, or across your whole network.

Optimize seamlessly

Dial in methods, steps, and recipes more precisely and efficiently than ever, with your whole team working from the same up-to-the-minute data.

Simplify handoffs with structured deliverables

Developing CMC deliverables in QbDVision means they’ll be structured, integrated, and ready to deliver Day 1. From QTPP to CPV, our platform flows your CMC data into a format that’s optimized for efficient intake by your partners or downstream sites.

Lower operational overhead

Spend less time gathering documents, consolidating data, and onboarding partners, and more time on science and engineering.

Trace every development step

Instantly add every change, update, and iteration to a gapless technical development history for internal teams, external partners, and auditors.

Provide real-time visibility

Give sending sites and external partners an up-to-the-second view of your processes, materials, and risk assessments, any time it’s needed.

Create a master structure for every transfer

Save time, drive efficiency, and reduce your risks by using QbDVision to centralize and standardize your senders’ CMC deliverables. With consistent data and knowledge structures every time, you can spend less time organizing documents and more time optimizing processes.

Protect 21 CFR compliance

Consolidate sender data in a secure, high-integrity platform that keeps your processes auditor- and regulatory- ready.

Master change management

Track every process iteration in a framework that instantly contextualizes every update for senders, partners, and auditors.

Simplify scale-outs

Create a consistent, scalable knowledge framework that gives every site the same view of your product and process requirements.

All your teams, data, and workflows. All in one dynamic workspace

Sending or receiving, successful tech transfers demand cross-functional collaboration. QbDVision makes that teamwork easier than ever.


Our platform gives your whole team a secure, centralized source of truth for all their critical process, product, materials, and risk information. Sharing data update, analyzing risks, contextualizing changes – in QbDVision, it’s easier than ever. For everyone.

Tech transfers, meet state-of-the-art transfer technology

End-to-end security

Keep your IP safe and your data compliant with best-in-class cybersecurity and access management protocols.

Modern data management

Turn your documents, folders, and SharePoints into productivity- and value-enhancing business resources.

Enhanced productivity

Free your team from from documents and get your scientists, engineers, and process experts back to what they do best.

After completing numerous tech transfers with QbDVision, I can’t imagine initiating one without it. It saves us time, money, and headaches at every step, even with complex biologic products.

Amol Thote, PhD
Sr. Director, Biologics Development, Bayer

OUR LATEST

Dive deeper with our CMC thought leaders

MORE INSIGHTS

Take a deep-dive with QbDVision Co-Founder & CEO, Yash Sabharwal.

MORE INSIGHTS

Explore new best practices and technology solutions with our CEO Yash Sabharwal and COO Luke Guerrero.

See the transformation for yourself

Schedule a consultation with our tech transfer experts today.

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

Board Advisor, QbDVision

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 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

Process & Knowledge Management Scientist, Bayer Pharmaceuticals | Ph.D., Drug Science

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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