Leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and
services Arriello (www.arriello.com) appoints respected regulatory expert Pete Embley as its first
Chief Regulatory Officer.
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.
Commenting on his ambitions for the company, Pete Embley says, “The increase in accelerated regulatory development pathways for personalized 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 recognizes 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. “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. 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,” says Embley.
“Regulatory is a key function within 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.”
Welcoming him to Arriello, CEO and co-founder Alan White says, “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.”
“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,” adds Anna Lukyanova, COO and co-founder, Arriello. “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, and managing the engagement with the CRO; and then helping with the Commercialization and Market Access pathway, 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. 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.”
Arriello has been providing risk management and compliance services to the life sciences sector since 2008. Its technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.