# Pharmacovigilance, Regulatory Services, Quality and Compliance: Global and local Pharmacovigilance services\. Quality Management and Regulatory Affairs solutions provider\. Consultancy from Development to Post\-Marketing\. Generated by Yoast SEO v27.5, this is an llms.txt file, meant for consumption by LLMs. ## Pages - [Leaders and Key Contacts](https://arriello.com/about-us/leaders-and-key-contacts/): Arriello leverages strategic acumen, pharmaceutical expertise, and intercultural proficiency to make your vision a reality\. - [Pharmacovigilance, Regulatory Services, Quality and Compliance](https://arriello.com/): Consultancy and services from development to market for Clinical, Regulatory, Pharmacovigilance, Auditing, and Safety Automation\. - [Local Affiliate Services](https://arriello.com/local-affiliate-services/): For global pharma, our local affiliate services offer crucial expertise in PV, regulatory, and quality, ensuring compliance worldwide\. - [MI and PV Services \| Medical Information \+ Pharmacovigilance](https://arriello.com/services/pharmacovigilance/mi-and-pv-services-medical-information-pharmacovigilance/): Our Global Pharmacovigilance System meets EU and local QPPV requirements throughout Development, Marketing authorization and Post\-authorization life\-cycle stages\. - [Orphan Drug Designation](https://arriello.com/regulatory-consulting/orphan-drug-designation/): EU and US orphan drug designation support for rare disease programs, from eligibility review to submission strategy and annual reporting\. ## News - [Arriello Named Best Life Sciences Clinical Safety \& Compliance Consultancy 2026](https://arriello.com/news/arriello-recognised-by-eu-business-news-2026/): Arriello has been recognised by EU Business News as Best Life Sciences Clinical Safety \& Compliance Consultancy 2026\. - [Arriello to Speak at PV UK \& EU 2026 as Silver Sponsor](https://arriello.com/news/arriello-to-speak-at-pv-uk-eu-2026-as-silver-sponsor/): Arriello’s Humaira Qureshi to speak and join expert panel at the 40th Pharmacovigilance UK \& EU 2026 conference in London, alongside Nargis Begum\. - [Arriello CEO Alan White Featured in Lifescience Insights 360](https://arriello.com/news/arriello-ceo-alan-white-featured-in-lifescience-insights-360/): Arriello CEO Alan White is featured in Lifescience Insights 360 \(November 2025\), discussing his vision for compliance as a strategic driver of global innovation\. - [Arriello Named Pharma Contract Services Company of the Year\!](https://arriello.com/news/arriello-wins-three-prestigious-categories-at-the-pharma-industry-awards/): Arriello wins Pharma Contract Services Company of the Year at the Pharma Industry Awards for exceptional performance, innovation, and client partnership\. - [Arriello Achieves ISO 27001 Certification \(Amtivo, INAB\)](https://arriello.com/news/arriello-certified-iso-27001/): Arriello earns ISO 27001 certification, demonstrating its dedication to data security, compliance, and trusted global life sciences services\. ## Article - [Why More Pharmacovigilance Cases Shouldn't Mean More Risk\.](https://arriello.com/article/the-volume-trap-why-more-pharmacovigilance-cases-shouldnt-mean-more-risk/): Discover how Arriello combines AI\-enabled case intake and expert oversight to scale pharmacovigilance without compromising quality or compliance\. - [Meet Vladimír Hrib, Global Drug Safety Associate and Project Manager at Arriello](https://arriello.com/article/meet-vladimir-hrib-global-drug-safety-associate-and-project-manager-at-arriello/): Meet Vladimír Hrib, Global Drug Safety Associate and Project Manager, sharing insights on pharmacovigilance, compliance and process improvement\. - [Meet Mihaela Trandafir, Regulatory Affairs Manager at Arriello](https://arriello.com/article/meet-mihaela-trandafir-regulatory-affairs-manager-at-arriello/): Meet Mihaela Trandafir, Arriello Regulatory Affairs Manager, and learn how she supports regulatory lifecycle management, clients, and patient access\. - [Enhance Patient Safety with Efficient PV Audit Program Management\.](https://arriello.com/article/enhance-patient-safety-with-efficient-pv-audit-program-management/): Streamline your audit program with Arriello's expert tips\. Ensure adherence to planned audits and optimize patient safety\. - [A Guide to Wholesale Distribution Authorization \(WDA\) in Europe\.](https://arriello.com/article/a-guide-to-wholesale-distribution-authorisation-wda-in-europe/): Learn who needs a WDA, master regulations, and navigate the supply chain with ease\. This guide unlocks the secrets of Wholesale Distribution Authorizations \(WDA\) for smooth product flow across the EU\. ## White paper - [The Strategic Advantage of Integrated Regulatory Affairs \& Pharmacovigilance\.](https://arriello.com/white-paper/the-strategic-advantage-of-integrated-regulatory-affairs-pharmacovigilance/): Learn how integrated Regulatory Affairs and Pharmacovigilance strengthen gene and cell therapy development, compliance and long\-term safety\. ## Case study - [Oncology Development Program: Pharmacovigilance Transition and Scale\-Up Support\.](https://arriello.com/case-studies/oncology-development-program-pharmacovigilance-transition-and-scale-up-support/): How Arriello supported a US biotech through PV transition, safety data migration and scale\-up from Phase I to Phase III oncology development\. - [Designing a Global Local Affiliate Model From The Ground Up](https://arriello.com/case-studies/designing-a-global-local-affiliate-model-from-the-ground-up/): How Arriello designed a scalable global affiliate PV and regulatory model, improving oversight, consistency, compliance and efficiency\. - [Scaling Local Affiliate Support\. Across 25\+ Countries](https://arriello.com/case-studies/scaling-local-affiliate-support-across-25-countries/): Arriello scaled affiliate PV support across 25\+ countries, migrated 1,200 safety cases and established inspection\-ready operations\. - [Bridging Resource Gaps in Regional Regulatory Affiliate Teams](https://arriello.com/case-studies/bridging-resource-gaps-in-regional-regulatory-affiliate-teams/): See how Arriello helped a global biotech maintain regulatory continuity across affiliates during post\-approval lifecycle resource gaps\. - [Rapid Stabilization of Multi\-Country Local Affiliate PV Operations](https://arriello.com/case-studies/rapid-stabilization-of-multi-country-local-affiliate-pv-operations/): See how Arriello stabilized multi\-country local affiliate PV operations with a scalable model for stronger compliance and oversight\. ## Brochure - [Regulatory Affairs Specialized Services Brochure\.](https://arriello.com/brochures/regulatory-affairs-specialized-services-brochure/): DEMO Strategic global life\-cycle management\. Regulatory Affairs Services Brochure\. - [Regulatory Affairs Services Brochure\.](https://arriello.com/brochures/regulatory-affairs-services-brochure/): Strategic global life\-cycle management\. Regulatory Affairs Services Brochure\. - [Customer Experience \(CX\) Program](https://arriello.com/brochures/customer-experience-cx-program/): Building lasting and beneficial partnerships by establishing, maintaining and improving the relationship with our clients\. - [Life at Arriello\.](https://arriello.com/brochures/life-at-arriello/): Find out more about how the recruitment process works\. - [Clinical Safety Services Brochure\.](https://arriello.com/brochures/clinical-safety-services-brochure/): Establishment and maintenance, case management, safety reporting\. Clinical Safety Services Brochure\. ## E\-book - [White Paper: IMPD vs IND: EU vs US Clinical Trial Submissions](https://arriello.com/guides-ebooks/white-paper-impd-vs-ind-eu-vs-us-clinical-trial-submissions-arriello/): Explore key EU CTA and US IND submission differences, including IMPD requirements, CTIS, FDA expectations, and global trial strategy\. - [White Paper: Gene \& Cell Therapy Regulatory and PV Strategy](https://arriello.com/guides-ebooks/white-paper-the-strategic-advantage-of-integrated-regulatory-affairs-pharmacovigilance/): Learn how integrated Regulatory Affairs and Pharmacovigilance strengthen gene and cell therapy development, compliance and long\-term safety\. - [PV Audit Strategy Guide\. Six steps to a compliant pharmacovigilance audit strategy\.](https://arriello.com/guides-ebooks/pv-audit-strategy-guide/): Six steps to a compliant pharmacovigilance audit strategy\. Arriello’s Auditing and Quality Assurance Manager Kamila Erbanova has created a new in\-depth and practical audit strategy guide that should help your PV QA team keep pace with regulatory requirements as product portfolios, supply chains, and PV risk landscapes evolve\. - [White Paper: Managing Technology Transfers for Finished Products in the EU\.](https://arriello.com/guides-ebooks/managing-technology-transfers-for-finished-products-in-the-eu/): Free whitepaper by Arriello, a leading provider of regulatory services: the intricacies and best practices for a successful transfer process\. - [Biotech Regulatory Strategy and Commercialization Planning: The challenges, changing priorities, and critical success factors\.](https://arriello.com/guides-ebooks/biotech-regulatory-strategy-and-commercialization-planning/): Discover six key insights from Arriello’s 2024 biotech survey, exploring regulatory challenges, market shifts, and commercialization strategies\. ## Optional - [Sitemap index](https://arriello.com/sitemap_index.xml)