Veristat Strengthens Regulatory Capabilities Across Europe and UK
Veristat, a scientific-minded global clinical research organization (CRO), announced today the expansion of its regulatory services capabilities by acquiring Drug Development and Regulation (DDR), a scientific and regulatory consultancy with offices in Barcelona and Amsterdam. This well-timed acquisition advances Veristat’s regulatory capacities in Europe and the United Kingdom (UK) as it works to accelerate the development of novel therapies for a growing number of biotech, pharmaceutical and medical device clients.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211111005506/en/
Montserrat (Montse) Barceló Riera, M.D. Vice President, Europe, Veristat and Xavier Luria, M.D. Founder and CEO, DDR, former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA)
Led by Founder and Chief Executive Officer, Xavier Luria, M.D.— former Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA) — DDR has carved out an impressive growth trajectory working with small to midsized companies largely involved in rare diseases and cancers, among others, and keenly interested in avoiding the implications of a less than ideal regulatory path to registration of their drugs and medical technology products. With its proficiency in European medical regulations in particular, the acquisition builds on the proven expertise of the Veristat team responsible for regulatory insight and action at a time when significant regulatory changes are afoot.
“Dr. Luria has built DDR into a company with a powerful reputation for the design, development and implementation of successful regulatory guidance, encompassing the alignment of multi-regional regulations, and proactive planning to resolve potential regulatory challenges,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Sponsors recognize that historical regulatory pathways are evolving, and regulatory agencies worldwide are offering greater opportunities for access and partnership. Architecting the ideal approach to optimize the path to a positive regulatory outcome requires collaboration with an experienced regulatory partner. The astute abilities of our team to interact with regulators and support positive results will no doubt serve our clients well.”
With DDR, Veristat will continue to deliver a flexible regulatory service model that provides end-to-end strategy, implementation and oversight of all related activities that ensure compliance with global regulatory requirements and swift approval.
“I am pleased to welcome the exceptional DDR team to the Veristat family here in Barcelona,” stated Montse Barceló Riera, M.D., Vice President, Europe for Veristat. “We are now able to provide our customers with a deeper understanding of the EMA and other key regulators, along with an expanded team fully committed to reducing time to market in important areas such as cell, gene, and RNA therapies.”
“Veristat exemplifies the core values DDR has embraced over the years,” stated Xavier Luria, M.D. “I am delighted to know that the company makes it a top priority to support and empower its people. Veristat is at the forefront of driving bold comprehensive clinical study strategies with a team unafraid of the big thinking required to get novel therapies to patients everywhere— quickly, safely and cost-effectively. On behalf of the entire DDR team, we look forward to supporting Veristat as a pre-eminent clinical research organization for the advancement of novel therapies across Europe, the UK, and worldwide.”
Drug Development and Regulation (DDR) is an independent European consultancy with offices in Barcelona and Amsterdam, focused on providing appropriate scientific and regulatory expertise for the global development and registration of drugs and medical devices. The Company’s tailor-made solutions contribute to the success of clients’ development programs across quality, nonclinical, clinical, and regulatory functions. The DDR team brings a track record of regulatory prowess supporting hundreds of MAAs and Agency Briefing Meetings, fully accustomed to the utmost regulatory standards to carry out any plan, including innovative products, re-profiling or hybrid drugs among others. DDR benefits from a network of highly qualified experts and strategic collaborations with renowned institutions worldwide.
Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years’ experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared nearly 100 marketing applications for approval with global regulatory authorities in the last 10 years.
Veristat's focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. We apply this knowledge base every day to solve any clinical program's challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Lauren L. Brennan, Director of Marketing
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
2021 World Conference on Science Literacy in Focus: Science Literacy for a Green Future6.12.2021 04:53:00 CET | Press release
On November 30, the 2021 World Conference on Science Literacy (WCSL) kick started in Beijing. With the theme of “Science Literacy for a Green Future”, the conference invited esteemed decision-makers, top scientists, renowned scholars, as well as leaders and representatives from key scientific and technological organizations (such as the United Nations Educational, Scientific and Cultural Organization, International Science Council, World Federation of Engineering Organizations, and The World Academy of Sciences for the advancement of science in developing countries). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211205005040/en/ Improving public science literacy and promoting low-carbon green transformation are among the topics they discussed. Together, the attendees shared their ideas, results, and experience of using science for green development, as well as contributing to an effective communication and partnership mecha
Alibaba Group Announces CFO Succession6.12.2021 01:22:00 CET | Press release
Alibaba Group Holding Limited (NYSE: BABA and HKEX: 9988, “Alibaba” or “Alibaba Group”) today announced that Toby Xu, Deputy Chief Financial Officer, will succeed Maggie Wu as the Company’s Chief Financial Officer, effective April 1, 2022. Maggie will continue as a partner in the Alibaba Partnership and serve as an executive director on the Alibaba board. “Maggie has made exceptional contributions that are instrumental to Alibaba’s achievements to date. Since joining Alibaba almost fifteen years ago, Maggie has helped lead three successful company public listings as CFO: Alibaba.com on the Hong Kong Stock Exchange in 2007, and Alibaba Group Holding on the New York Stock Exchange in 2014 and on the Hong Kong Stock Exchange in 2019. She has built and nurtured a finance team with professional capabilities and accomplishments second to none, and has served as our bedrock in pursuing Alibaba’s strategies and business development. Maggie is forever calm and unflappable, regardless of ups and
NextSense Emerges to Unlock Brain Health with Key Partners UCB, Heraeus, UC San Diego, and Emory University3.12.2021 16:00:00 CET | Press release
NextSense, the foundation of brain health, came out of stealth with an announcement made from the AES (American Epilepsy Society) Annual Meeting in Chicago, where NextSense and its partners are presenting the results of their research on seizure detection to peers in academia and industry for the first time. NextSense unlocks brain health with real world data insights and practical, scientific wisdom for daily living. Traditional brain health monitoring technology like EEG machines and polysomnograms are too bulky for home use, requiring patients to stay overnight at hospitals or sleep study clinics for observation. The high cost of care and lack of comfort of these devices makes long-term and continuous monitoring nearly impossible. Not only are these data based on a single timeframe, they observe what is anything but an ordinary night’s sleep. And for anyone living with epilepsy, the unpredictability of seizures makes direct observation and high-quality data-gathering exceedingly rar
Healthcare + Expo Taiwan to Build an Ecosystem of Digital Transformation in Healthcare3.12.2021 15:15:00 CET | Press release
One of the largest trade fairs in the APAC region- the Healthcare+ Expo Taiwan- takes place on 2 to 5 December in Taipei. The Expo displays Taiwan’s strength in AI, Cloud-based Applications, Flat Panels, IoT and Technologies that make up Metaverse, reflecting the trend on digital transformation in healthcare driven by the global pandemic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005002/en/ Expand Businesses into growing markets in the APAC region, with Healthcare+ B2B. Join medical institutes and companies in the fields of pharmaceuticals, biotechnology, health/ information technology, electronics and manufacturing to promote products, build partnerships and seize supply-demand opportunities. (Graphic: Business Wire) The Expo has an all-star lineup of corporates, including Acer, Asus, AUO, Delta Electronics, Innolux, Quanta and Wistron, demonstrate their technologies and solutions tailored to digital transformati
Eurofins Technologies Launches a New Multiplex RT-PCR Assay for Combined SARS-CoV-2 Screening and Rapid Detection of the Omicron (B.1.1.529) Variant of Concern3.12.2021 14:05:00 CET | Press release
Eurofins Technologies (Paris:ERF) announces the launch of the multiplex RT-PCR assay GSD NovaType Detect + Select K417N SARS-CoV-2. Within just one week since the first reports on the Omicron variant of concern, this kit has been developed as a quick response to identify its presence. The assay is designed for the simultaneous qualitative detection of SARS-CoV-2 genomic RNA and identification of the spike (S) mutation K417N in one reaction. The results of this RT-PCR assay can be obtained within 1 hour, which makes it a fast and cost-effective solution to identifying the presence of the Omicron variant before samples are confirmed by whole genome sequencing. Eurofins Technologies is constantly working to adapt its product offering to meet the challenges of the ongoing COVID-19 pandemic.. For more information, please visit Eurofins Technologies website. About Eurofins Technologies – a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection m
How Can Chinese Cities Increase Their Global Communications Impact? Joint Report and Index from CCG and Xinhuanet Sizes up Strategies and Offers Valuable Suggestions3.12.2021 13:53:00 CET | Press release
The Center for China and Globalization (CCG) and Xinhuanet, China’s leading online news portal, recently released a joint report evaluating the global communications impact of Chinese cities, analyzing the problems with their communication strategies, and offering suggestions on improving their ability to “go global”. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005279/en/ Report on the Chinese Cities Global Communications Impact Index (CCGCII) & Ranking of Chinese Cities by Global Communications Impact (Graphic: Business Wire) The study covered the top 100 cities in China as ranked by GDP in 2019, including Shanghai, Beijing, Shenzhen, Guangzhou, Chongqing, Chengdu, Wuhan, Tianjin, Dalian, and Xiamen . Based on big data from the Xinhua RIS data bank, which has collated over 10 million items of public information from overseas mainstream media and international social media platforms, the Chinese Cities Global Commun
Valuence Japan Nanboya, BRAND CONCIER Recognized as No.1 in Five Categories in Japan, Including for Overall Purchase Volume, for Luxury Brand Goods and Other Items!3.12.2021 10:55:00 CET | Press release
Valuence Japan Inc. (Tokyo; Susumu Muguruma, representative director), a member of the Valuence Group (TOKYO:9270), which operates 135 offices in Japan and 23 other countries(*1) specializing in the purchase of watches, bags, jewelry, precious metals, antiques, and art objects has announced the results of a survey on the purchase volume of brand goods conducted by ESP Research Institute, Inc. According to the survey, the company’s Nanboya and BRAND CONCIER brands placed in the top position in Japan in terms of overall annual purchase volume of luxury brand goods. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211203005167/en/ Valuence Japan Nanboya, BRAND CONCIER Recognized as No.1 in Five Categories in Japan, Including for Overall Purchase Volume, for Luxury Brand Goods and Other Items! Also Recognized as No.1 in Japan for Purchase Volume of Rolex and Other Watches, Jewelry, Apparel, and Accessories (Graphic: Business Wire)