Regulatory is a key function within in the pharma and biotech world, so it feels right to join a business that positions this as a pivotal part of the business.
DUBLIN (PRWEB)
November 29, 2022
Arriello, a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has appointed respected regulatory expert Pete Embley as Chief Regulatory Officer, signalling the company’s commitment to growing its pre-approval service line.
The move comes as soaring biotech activity in both Europe and the US is driving strong demand for an integrated, high-touch service offering Regulatory, Quality Assurance (QA) and Pharmacovigilance (PV). The catalyst is the rise in young and ambitious biopharma companies which are seeking end-to-end support from early development of new technologies, including Advanced Therapy Medicinal Products (ATMPs), and market expansion, to longer-term safety monitoring and risk management including continuous quality management and assurance right along the supply chain.
Pete, who joined Arriello in September and is based in Oxford in the UK, is the company’s first Chief Regulatory Officer. His appointment is another important milestone for the fast-growing service provider.
Commenting on his ambitions for the company, he said, “The increase in accelerated regulatory development pathways for personalised and rare disease therapies demands an integrated Regulatory, Pharmacovigilance and QA service offering from a much earlier stage. Accelerated pathways trigger an earlier and more intensive engagement with Regulatory agencies. Arriello recognises this and my new role will reflect our strong commitment to fulfilling these combined needs with an optimised cross-discipline service from the earliest point of need.”
Pete is a highly experienced consultant, having worked in the pharmaceuticals industry for more than two decades, spanning Regulatory positions with increasing responsibilities at Norton Healthcare, GlaxoSmithKline, IVAX, Ranbaxy, Chugai Pharma Europe, PPD, Voisin Life Sciences Consulting and, most recently, Bionical Emas.
Pete has known Arriello since the company’s inception, having previously worked with the co-founders Alan White and Anna Lukyanova.
He said, “When Alan and Anna formed Arriello, the company was focused primarily on the maturing PV industry. I have followed the company’s evolution very closely and it got to the point where I just couldn’t turn down the opportunity to join this dynamic and very successful business, whose value is inextricably linked to the calibre of its people.”
He added, “My role is to develop the Pre-Approval service line, and complement Arriello’s well-established post-approval services. This expansion couldn’t be better timed, and I couldn’t be more excited at the opportunity ahead of us.
“Regulatory is a key function within in the pharma and biotech world, so it feels right to join a business that positions this as a pivotal part of the business. It’s this clear definition which means we can give our clients the optimum support they need in getting to market and maintaining compliance.”
Pete will be growing the full-service client base, with ambitions to further enhance the wraparound support for ambitious biotechs, to include help with Commercialisation and Market Access.
Welcoming him to Arriello, CEO and co-founder Alan White said, “Anna and I, and indeed the whole of the Arriello family, are delighted that Pete has come on board at this exciting time. His deep Regulatory expertise and broad experience will be instrumental in expanding our offering to fulfil more of our clients’ needs as ambitions around therapies for rare diseases soar. Our clients couldn’t be in better hands.
Anna Lukyanova, COO, and co-founder, said, “Pete’s appointment is important and very timely, and we welcome him warmly. Now more than ever, Arriello is in a position both to help homegrown European biopharma companies progress their developments and provide a gateway into Europe for US biotechs. Today, we can provide comprehensive support from a very early stage – across Regulatory strategy to get into clinical trials; providing the scientific advice and clinical trial applications support, managing the engagement with the CRO; and then helping with the Commercialisation and Market Access pathway. And that’s all while taking care of the product’s safety profile, as well as the evolving quality management system as the scope of our clients’ activities – and their data – grows.”
She continued, “We’re also thrilled at what this means for our own people. Growing our Pre-Approval services will provide a chance for existing teams to further develop their Regulatory skills and knowledge, making Arriello an even more attractive place to work.”
Over the last year, Arriello has made a number of strategic senior appointments, including Kieran O’Donnell as VP of Drug Safety and Principal Consultant for Pharmacovigilance, and Helen Lowe as Auditing & QA Director.
About Arriello
Arriello has been providing risk management and compliance services to the life sciences sector since 2008. These services include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety, and quality and compliance auditing systems.
Headquartered in Ireland, with European operations in Central Europe, our technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
More at http://www.arriello.com and @Arriello
Media contact:
Carina Birt
Sarum Life Sciences for Arriello
carina@sarumlifesciences.com
+44 7970 006624