Neemt Drug Development and Regulation (DDR) over, een adviesbureau op het gebied van regelgeving onder leiding van voormalig senior officer bij European Medicines Agency (EMA)

SOUTHBOROUGH, Mass.–(BUSINESS WIRE)– Veristat, een wetenschappelijk ingestelde wereldwijde klinische onderzoeksorganisatie (CRO), heeft vandaag de uitbreiding aangekondigd van haar capaciteiten op het gebied van regelgevende diensten door de overname van Drug Development and Regulation (DDR), een wetenschappelijk en regelgevend adviesbureau met kantoren in Barcelona en Amsterdam. Deze goed getimede acquisitie bevordert de regelgevende capaciteiten van Veristat in Europa en het Verenigd Koninkrijk (VK) omdat het werkt aan het versnellen van de ontwikkeling van nieuwe therapieën voor een groeiend aantal biotech-, farmaceutische en medische klanten.

Onder leiding van oprichter en Chief Executive Officer, Xavier Luria, MD – voormalig hoofd van de veiligheid en werkzaamheid van geneesmiddelen bij het Europees Geneesmiddelenbureau (EMA) – heeft DDR een indrukwekkend groeitraject uitgestippeld door samen te werken met kleine tot middelgrote bedrijven die grotendeels betrokken zijn bij zeldzame ziekten en onder meer kanker, en zeer geïnteresseerd in het vermijden van de implicaties van een minder dan ideaal regelgevend pad voor de registratie van hun medicijnen en medisch-technologische producten. Met zijn vaardigheid in de Europese medische regelgeving in het bijzonder, bouwt de overname voort op de bewezen expertise van het Veristat-team dat verantwoordelijk is voor inzicht in en actie op het gebied van regelgeving in een tijd waarin belangrijke veranderingen in de regelgeving op stapel staan.

Veristat Strengthens Regulatory Capabilities Across Europe and UK

Acquires Drug Development and Regulation (DDR), a regulatory consultancy led by former senior officer at European Medicines Agency (EMA)

SOUTHBOROUGH, Mass.–(BUSINESS WIRE)– 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.

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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.”

About DDR

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.

About Veristat

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.

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Contacts

Veristat:
Lauren L. Brennan, Director of Marketing

media@veristat.com