CA-VALGENESIS
14.6.2022 14:02:05 CEST | Business Wire | Press release
ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in manufacturing sciences and technologies (MS&T) that enable the world’s most successful life sciences companies to model their risk management programs and improve process performance across the entire GMP lifecycle.
The acquisition was initiated when ValGenesis leadership saw the strategic product synergy for customers requiring a complete and more integrated platform across the validation lifecycle focusing on Pharma 4.0. The acquisition was completed on June 6th, 2022.
A pioneer of 100% paperless validation technology with 30 of the top 50 global life sciences companies using ValGenesis VLMS as the system of record for their validation programs, ValGenesis has steadily expanded its product vision beyond core validation into a holistic manufacturing intelligence platform. The acquisition of 4TE accelerates that vision. 4TE’s advanced risk management platform (iRISK Platform® ), used by 10 of the top 30 global life science companies, enables comprehensive risk management in the product lifecycle. In addition, 4TE’s continuous process verification software system (iSEE Platform™ ) enables real-time Stage 3 monitoring for process validation and supports Annual Product Quality Reviews (APQR). ValGenesis Validation Lifecycle Management System (VLMS) remains the industry standard for Stage 2 validation.
The acquisition also provides ValGenesis a boosted presence in the European and LATAM markets and access to a driven, talented team. The Lisbon office of 4TE will continue to orchestrate the development and go-to-market plans of iRisk and iSee with bolstering support from ValGenesis.
“The future never looked brighter for ValGenesis and 4TE employees, partners, customers, and the entire life sciences industry. This acquisition advances our Validation 4.0 strategy. 4TE’s product quality, individual talent, and passion for customers perfectly match ValGenesis’ corporate culture. We look forward to Prof. Dr. José Menezes and 4TE’s talented team joining ValGenesis, further cultivating a shared culture of innovation and driving even greater value for our customers.” says Dr. Siva Samy, CEO of ValGenesis. “As Pharma 4.0 becomes a reality, we continue to expand our product roadmap beyond core validation, driven by strong business values and commitment to the life sciences,” he stated.
The complementary functionality of their respective products ensures minimal product overlap. This presents minimal disruption and maximum upside for ValGenesis and 4TE customers. The combined offering is the most complete “validation lifecycle” platform on the market delivered by a single vendor. With a unified development team, a more robust roadmap, and an expanded services portfolio, ValGenesis is achieving its vision of becoming the de facto Validation 4.0 standard to lead life sciences companies in their journey toward Pharma 4.0.
Prof. Dr. José C. Menezes, Chairman, and founder of 4Tune Engineering, said, “We are excited to join ValGenesis. We share a similar vision about the challenges and solutions required by pharma, biopharma, and the new advanced medicinal therapeutic products, in terms of accelerated development and robust science- and risk-based approaches to better serve patients. Our integration into ValGenesis will provide our worldwide customers access to automated, systematic, and user-friendly tools for risk and validation lifecycle management programs to improve mission-critical business processes in the life science companies. Our unified company will also accelerate the development and innovation of future-ready solutions targeting advanced product portfolio management.”
About ValGenesis
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
For more information, visit www.valgenesis.com
For information on the acquisition, visit: https://www.valgenesis.com/4TE
View source version on businesswire.com: https://www.businesswire.com/news/home/20220614005044/en/
Link:
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Daiichi Sankyo Appoints Markus Kosch to Lead Europe Business as Part of New Commercialization Organization24.8.2026 10:00:00 CEST | Press release
Daiichi Sankyo (TSE: 4568) today announced the appointment of Markus Kosch, MD, as Head of Europe Business, effective April 1, 2027. In this role, he will lead the company's European business within the new globally integrated Commercialization Unit and serve as General Manager of Daiichi Sankyo Europe GmbH, with legal responsibility for the company in Europe. The appointment reflects the next phase of growth of Daiichi Sankyo under its Five-Year Business Plan and the establishment of a new Commercialization Unit. Within this new structure, Markus Kosch will bring together the Oncology and Specialty businesses in Europe under one integrated leadership model to help bring innovative medicines to more patients across the region. For the past five years, Markus Kosch has led the Daiichi Sankyo Oncology Business Division in Europe and Canada, overseeing a period of significant growth and preparing the organization for an increasingly expanding oncology portfolio. Prior to joining Daiichi S
European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union24.8.2026 09:01:00 CEST | Press release
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only treatment approved for Rett syndrome in the European Union (EU). “The approval of DAYBU marks a significant milestone for the Rett syndrome community in the EU and advances our mission to bring this innovative treatment to patients and families who have long faced a profound unmet medical need,” said Catherine Owen Adams, Acadia’s Chief Executive Officer. “For people living with Rett syndrome, a devastating rare neurodevelopmental disorder, there have been no approved treatment options in the EU. We are proud to make DAYBU available and look forward to supporting patients, caregivers, and healthcare providers gain access to treatment." The DAYBU marketing authorization in the EU is prim
ORZEYFUL (oveporexton) Approved in Japan as the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 124.8.2026 08:36:00 CEST | Press release
Discovered by Takeda in Japan, ORZEYFUL has the Potential to Redefine Care Beyond Individual Symptom Management for Adults Living with Narcolepsy Type 1 (NT1) Landmark Phase 3 Studies Demonstrated Significant and Meaningful Improvements Across the Full Range of NT1 Symptoms Evaluated in Clinical Trials Compared to Placebo Milestone Marks Third Major Regulatory Approval Secured for ORZEYFUL Around the World Takeda (TOKYO:4502/NYSE:TAK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist and the only medicine indicated in Japan to treat the disease holistically rather than individual symptoms. The discovery of this new class of medicine originated in Takeda's laboratories in Japan. Takeda is proceeding with launch preparations and expects to make ORZEYFUL available as quickly
Fasset Hits $1B Valuation as SBI Group Leads $68M Series C to Scale AI-Powered Stablecoin Neobanking24.8.2026 08:03:00 CEST | Press release
Round led by SBI Group follows $51 million Series B raise in May 2026, marking ascent as one of the fastest-growing neobanking platforms. Capital will expand Own Network and deepen AI across stablecoin settlement, tokenization, and corridor banking. Fasset now processes more than $40 billion in annualized transaction volume, serving 3 million+ wallets and more than 1,000 enterprises across 125 countries. Fasset, the AI-powered stablecoin neobanking platform, today announced it has raised $68 million in Series C funding at a $1 billion valuation. The financing was led by SBI Group and follows Fasset’s $51 million Series B earlier this year, which brought Speedinvest onto the cap table alongside a group of strategic investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260823503947/en/ Mohammad Raafi Hossain, Co-Founder and CEO, Fasset The new capital will support the expansion of Own Network, Fasset’s regulated financial
Zanders Expands DACH Region with New Office in Vienna, Austria24.8.2026 07:11:00 CEST | Press release
Zanders, the global treasury, risk, and technology consultancy, today announced a significant expansion of its DACH region with the opening of a new office in Vienna. The move builds on Zanders' continued growth across Germany, Austria, and Switzerland, and marks another step in the firm's strategy of deepening its presence in the markets where client demand for specialized treasury, risk, and corporate finance advisory is growing fastest. DACH has been one of Zanders' priority regions for several years, with the firm steadily expanding its team and client base across Germany and Switzerland. Austria represents a natural next step in that growth: in conversations with clients in the market, Zanders has seen growing interest in treasury transformation and financing support, as companies work through interest rate volatility, refinancing needs, and a broader shift toward more digitized, centralized treasury operations. The new Vienna office allows Zanders to be closer to clients' operati
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom