Xybion Life Sciences

Unifying R&D, Regulated Lab Operations, Quality, Risk, Compliance & Safety:
All-In-One Cloud Platform

Xybion Life Sciences

Xybion offers a comprehensive suite of solutions for the Life Sciences sector.  We are helping Life Sciences companies to solve business problems and add new capabilities to make them more productive and innovative. Our company was founded and continues to focus on helping companies operate in compliance with regulatory requirements. Life Sciences present unique challenges in the scope and volume of regulations both nationally and globally. Our team of experts develops software products and provides services to create unique industry-specific solutions.  These solutions include a wide range of functional areas including:

Preclinical Solutions

Software and services that automate and streamline preclinical and drug discovery business.

Digital Lab Management Solution

Lab Management Systems such as LIMS, ELN, Lab Data Management, Analytics, and submissions.

Risk & Compliance

Comprehensive Quality and Compliance Solution to predict business risk using Xybion FDA 483 database. Our services include CSV, Quality Management, and Audits.

Quality Management

Software that helps to define and to manage quality systems including policies, SOPs, Employee training, Audits, Deviation, and CAPA.

Validation

Validation as a service and validation automation.

Asset Management

Software and services to help you maintain your vast array of physical assets.

We have Partnered with Life Sciences Companies for Over 40 Years.

Our Solutions

Bio-Pharmaceutical Research & Development

Protocol Management

Preclinical & Drug Discovery Solutions

Lab Animal Science

Laboratory & Sponsor Operations Management

Drug Stability & Sample Management

Formulation & Clinical Supply

Instrument, Equipment & Facility Management

Data Warehouse & SEND Submissions

Clinical Trial Management

Audit Readiness, Deviation & CAPA

Learning Management

Predictive Compliance & Quality Management

Validation Service & Validation Automation

Enterprise Content Management

SEND as a Service

Life Sciences companies face many unique challenges. In an age of enhanced consumer awareness and FDA initiatives surrounding pharmaceutical quality, companies focus on product quality throughout the product lifecycle to reduce operational and reputational impacts and costly product recalls. In addition, regulatory, revenue, channel, and competitive pressures make it increasingly important for these companies to foster quality resources for profitable growth. At Xybion, through our family of solutions, deep domain experience, and work experience of over 40 years, we can help Life Sciences companies solve business problems and create improved business capabilities.

Compliance, Quality & Risk

Quality Management System (QMS)

Compliance Prediction & Business Risk Assessment

Quality Audits

Third-Party Audit Solution & Service

Document Management System (DMS)

21 CFR Part 11 Compliance

Validation Services

Solutions For Manufacturing

Quality improvement and control are the most important business concerns for manufacturers worldwide. The common goal shared by all small, medium, and large manufacturers is to continuously improve the quality, effectiveness, and profitability of their operations. To compete better and to continue to be a preferred supplier to their customers, manufacturers need to follow best practices and conform to applicable regulatory requirements.  Many will also implement quality standards such as ISO to reduce costs, shorten the production cycle and improve overall performance and compliance.

 

Xybion provides a comprehensive suite of technology and services that are designed to help manufacturers improve performance and reduce costs. Core solutions include:

Quality Management

Governance, Risk & Compliance Solutions

Equipment Qualification & System Validation

Records & Information Management

Asset & Maintenance Management

Deviation Tracking & CAPA

QC Lab Automation

Batch Record Review Automation

Data Integrity

GxP Audit

Third-Party / Supplier Audit

Xybion’ software solution, CQRM XD, is designed to help run operations efficiently and flawlessly. Automating processes for quality management, document management, risk management, change control, and other complex processes is our expertise. CQRM XD enables manufacturers to comply with ISO and other industry standards, reduce manual operations and helps them proactively identify, and resolve quality issues. Xybion offers comprehensive industry solutions for manufacturers including CQRM XD, quality management, Enterprise Asset Management, and Enterprise Content Management solutions.

Sales & Marketing

Ethics & Compliance in Sales

Website Content Compliance

Enterprise Content Management

Procurement

Xybion contract compliance solution automates the following activities. Our solution helps improve the procurement/contract team productivity by up to 70%. A typical SOW may take 30 minutes to review manually, but Xybion’s solution can review and compile the status report in under one minute.

SOW / MSA / Contract Review

Vendor SLA Review

Invoice Review and Invoice Compliance with SOW

Score Card Comparison

Vendor Quality Scorecard

Supplier Risk Management

Supplier Audit

Ready to learn more? Book a free demo.

Heidi Krueger

Head of Quality Assurance

Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.

James Castonguay

Product Technology Lead

James provides leadership to Xybion quality management systems including product design, development and client delivery. James started working with Xybion in 2002 in its Canadian division. He is now managing product delivery from the United States. James has a master’s degree in mathematics and minor in informatics from the University of Sherbrook, Quebec, Canada.

Dave Chiaramonte

Enterprise Assets and HSE Leader
Dave brings diverse and deep expertise to his leadership role as the leader of Enterprise Asset Management (EAM) and Employee Health & Safety line of business. Dave has over twenty years of experience within the Information Technology industry including development, implementation and integration of complex Enterprise Systems in large corporate environments. He is a highly regarded technology leader in IBM’s Maximo Asset Management Product implementation. Dave worked with BMS and Dupont pharmaceuticals before joining Xybion in 2004.

Tom Klapmuts

Digital Lab Solution Leader

Tom provides leadership in design, delivery and revenue growth of Xybion digital lab solutions. He is an experienced client solutions manager with a demonstrated history of working with many clients globally to solve their business problems. Tom has training in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Life Sciences, CRO Management, and Clinical Development. Before joining Xybion, Tom worked for pharmaceutical companies such as Merck and Schering Plough. Tom is a Purdue university alumnus.

Priya Rajesh

Head of Sales: APAC & EMEA

Priya is responsible for Xybion business growth in APAC and EMEA region. She brings over 18 years of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.

Raji Bijur

Head of Quality Control & CSV

Raji leads Xybion Quality Control function. She has over 22 years of experience in software quality management, CSV, SQA, software process & KPI development and industry benchmarking. She has strong process implementation knowledge including ISO, CMMI, Agile, Scrum, Six Sigma, Lean. Certified CSQA, CSV, GCP, and GAMP. Raji has led implementation of QC processes in Robotic Process Automation (RPA) projects. Before coming to Xybion in 2019, she worked with IQVIA (Former Quintiles), Infosys, Aris Global, Mphasis and serving clients across different market segments. Raji has a bachelor’s degree in information science & technology and MBA from Indian Institute of Management, Ahmedabad.

Bob Friedman

Chief Solution Architect

Bob Friedman has over 25 years of experience in Preclinical information systems at Xybion Corporation as a developer, development manager and Chief Solution Architect. He has been an active member of the CDISC SEND standards consortium for five years as well as the PhUSE / FDA Industry Collaboration. Bob has previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health. He has a master’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

Gokul Panda

Head of Platform and Product Development

Gokul is the Head of Platform and Product Development, responsible for developing new and critical platforms and products. He has over 20 years of enterprise software development in the life sciences industry and related fields. Gokul holds both a Bachelor’s Degree and Master’s Degree in Engineering from the Indian Institute of Engineering, Science, and Technology. Gokul’s unrivaled expertise in enterprise software architecture and solutions provides Xybion’s clients with leading product functionality, innovation, and platform stability.

Anu Roy

Chief Solutions Delivery Officer

Anu manages project delivery and relationship. She has over 18 years of Life Sciences industry and IT services experience. Anu has a strong track record of designing and developing digital solutions, management consulting, quality & compliance Management, CLM, process & key metrics design, program execution & improvement and account management. Anu is a recipient of the STEM WOC ‘Technology Rising Star ‘by US Women’s magazine in 2014. She has received several other awards including Infosys Consulting Architect Award for outstanding achievement in 2011, RCL Crown Golden Brain Award in 2013. Anu is a guest columnist at Pharmaceutical Compliance Monitor and published in several international business magazines. Anu has a bachelor’s degree in Biochemistry and MBA in marketing.

Keith Dempsey

Chief Information Officer

Keith Dempsey has joined Xybion as our global CIO. He brings 20+ years of progressive Information Technology experience from Merck, AIG, Barclays and PriceWaterhouse. Focusing his career on building global strategies that capitalize on progressive technologies that scale in accordance to realized business growth. His experiences range from introducing new technologies that facilitated a competitive advantage for Merck, introduced new and scalable technologies for AIG Investments, and created progressive global organizational improvements for Barclay’s Capital. Keith has a degree in Chemical Engineering from Clarkson University and an MBA from William Paterson University.

Steve Porfano

Executive Vice President & Chief Financial Officer

Steve manages Xybion corporate function which includes Finance, HR, Legal and QA. Steve joined Xybion in 1989 as Corporate Controller and was promoted to Chief Financial Officer in 1991. As Chief Financial Officer, Steve is responsible for the establishment, enhancement, coordination and administration of the Company’s financial systems, internal controls, and related areas. Additionally, he is the corporate liaison to the Company’s bank, independent certified public accounting firm and governmental compliance and financial auditors.

Kamal Biswas

President & Chief Operating Officer

Kamal joined Xybion as its President and Chief Operating Officer in 2018. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. Very recently, Kamal was a Partner and leader of the global Life Sciences practice at Infosys Consulting. Before that, he spent several years working with pharma companies including Novartis Pharma and Ciba Geigy to manage manufacturing and late-stage R&D functions.

Pradip K. Banerjee, Ph.D., MBA

Chairman of the Board & Chief Executive Officer

Dr. Banerjee is an entrepreneurial senior executive with 30+ years of in-depth experience in the global Life Sciences, Healthcare and Services industry in global operations, strategic management, business development, investments and new ventures creation, M&A and Buy-outs. Prior to acquiring Xybion in 2008, Pradip served as President and CEO of Science Center in Philadelphia focused on creating, incubating, managing and investing in science based new companies. He was the Partner-in-Charge of the pharmaceutical Research & Development unit of Accenture where he created the R&D consulting unit and had grown it to become $100+ million worldwide business. Dr. Banerjee holds a Ph.D. in Pharmaceutical Sciences from University of Wisconsin-Madison and an MBA from the Wharton Business School of University of Pennsylvania.

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