Epista Life Science

Exciting Alliance Announcement! 📢🤝 We are thrilled to announce the alliance between Epista Life Science and DNAnexus!💫 By joining forces, we leverage our combined expertise and resources to provide groundbreaking solutions and comprehensive data management for the life sciences community. ✅✅ This alliance marks another significant milestone in our commitment to advancing life science research and innovation. Together with DNAnexus, we are bringing trusted regulatory spaces (TRS) to the life science industry, encouraging convergence – expediting cloud-based collaborative review   Please contact us for more information. Reach out to Toni Lakin-Ritter at [email protected] 📧

We’re pleased to introduce you to Epista Life Science’s Commercial & Medical Excellence services! ✅✅   Our unique focus on Operational Excellence in Customer Engagement sets us apart. We offer end-to-end services spanning business consulting, technology implementation, and operations. Our key areas of focus are customer and content excellence, and we ensure commercial compliance.   At Epista, we pride ourselves in our team of highly experienced professionals, each with over 20 years of industry experience. Their expertise allows us to offer support from the end of phase 2 and beyond, assisting in operationalizing business and technology strategies to fully commercialize. 💡   Epista offers a comprehensive range of services to assist in various areas, such as setting up the right compliance organization, SOP generation, compliance health checks, and advice to ensure all processes and documents meet regulatory standards. We also support KOL development & management, FDA and EMA submission preparation, and more.   Please contact Sara Davies, Head of Sales, Commercial & Medical Excellence, to hear more about how Epista can help you. ✨ #LifeScience #EpistaLifeScience #PreCommercial

An exciting addition to the Epista team before the Veeva Summit R&D and Quality in Boston on September 9th and 10th!🎉 We are thrilled to announce Haik Gazarian's addition to the Epista family as Head of Quality (US department). Haik will join our team at the upcoming Veeva Summit R&D and Quality in Boston, where Epista is a Silver Sponsor. Until recently, Haik was a quality business leader and program owner at Veeva Systems. He has vital expertise in process improvement, program design, best-practice implementation methodology, and solution delivery. We are delighted to have such a proficient strategist on our team. Welcome to the Epista Family, Haik Gazarian🚀 You can access more detailed information regarding Haik Gazarian's accomplishments and understand why we consider him a remarkable fit for Epista by visiting the following link: https://lnkd.in/dbx5PDVN Once again, if you want to discuss our involvement in the upcoming Veeva Summit R&D and Quality, please get in touch with Toni Lakin-Ritter or Flemming Kjoeller in advance. ✨

Congratulations on your five-year anniversary, Karin Hesslevik! 🎉 Karin, Principal Consultant, has been an invaluable part of the Epista family since 2019, contributing her expertise to a wide variety of impactful projects and assignments. She has accumulated extensive experience, encompassing system implementations, rewriting, and the establishment of foundational guidelines for IT compliance. "I find great fulfillment in taking on various tasks and have accumulated much experience, especially in strategic project planning, process improvements, and sales. Being a part of projects contributing to process and business improvements has been incredibly rewarding. I am eager to take on new challenges and opportunities while being a part of Epista’s continuous growth." Thank you, Karin. We appreciate your ongoing commitment and participation. We are excited for many years to come with you on our team! ✨💜 #LifeScience #EpistaLifeScience

We are thrilled to announce the addition of five new members to the Epista Life Science family! 🚀 Welcome to Rezan Murad, Michael Agard, Haizea Goñi Erro, Rikke Nerløe & Emil Blume Vollandt 🎉 Each of the latest members will help us anticipate our journey of reaching new heights and ambitions for the Life Science industry. To fulfill our ambitions, we always seek great talent, expertise, and skills to enrich our industry advancement mission. 💫 Are you curious about joining the Epista family? Learn more about our career opportunities at: https://lnkd.in/de4s5nm ✅✅✅ #LifeScience

Unlocking funding for Manufacturing Execution Systems (MES) can be a challenging task, especially when there's a tug-of-war for corporate budgets. Our MES Business Case Analysis is a game-changer! ⭐Provides a comprehensive, systematic assessment of the benefits ⭐Evaluates costs for transitioning to a digitally operated production Our analysis will help you make an informed decision based upon facts, and secure the necessary funding for the MES investment. Ready to transform your production processes? Discover how our MES Business Case Analysis can pave the way for a seamless transition to a digitally operated production. Developped by Thomas Halfmann.

Keep up with taxonomy changes with Epista Life Science! ✅   As Content types (Taxonomy) are changing in PromoMats, have you considered the broader impact over & above mapping your newly created content to the new Taxonomy?   The changed taxonomy may make archived and approved for reuse materials challenging to find. Your work instructions / SOPs / Guidelines & training must also be updated. ⛔   Epista Life Science can help with this. Please contact Sara Davies, Head of Sales, Commercial & Medical Excellence, to discuss it further. ✨

Epista Life Science will attend the CDISC + TMF US Interchange in Phoenix/Scottsdale in October 2024!🚀 US-based members of the Epista family, Brooke C. (Vice President, Advisory and Delivery), Michael Agard, and Katherine Novak (Principal Consultants), are attending the CDISC conference in Phoenix/Scottsdale on October 23rd and 24th. 🎉 📅 On the 23rd of October: - Brooke C. will present on ICH Initiatives M4Q(r2)/Q12/M11 and Global Harmonization; Impacts on Regulatory Submissions. 💡 📅 On the 24th of October: - Michael Agard will share insights on Applying Quality by Design to TMF Risk Management.💡 - Katherine Novak will present on Streamlining the TMF Reference Model for Optimal Clinical Trial Document Management.💡 Please stay tuned for updates from our US Super team on our appearance at the upcoming conference. ✅ We are looking forward to some inspiring and enlightening days in Phoenix! ✨ Link for the complete program: https://lnkd.in/gnByUH52 #LifeScience  #CDISCInterchange #Pharma #Epista #LifeScience #LifeScienceNews #ClinicalData #TMF

Leverage Your ATMP Manufacturing with Digitalization Advanced Therapy Medicinal Products (ATMPs)—medicines based on genes, tissues, or cells—require unique and sensitive manufacturing approaches. To ensure patient safety and achieve superior outcomes, it's crucial to digitalize your manufacturing process. Digitalization delivers: ⭐Patient Safety ⭐End-to-End Traceability ⭐Improved Process Control ⭐Informed Decision-Making Ready to transform your ATMP manufacturing? Discover our proven methodology to swiftly and reliably digitalize your ATMP manufacturing processes. Developed by Hernan Vilas, life science manufacturing expert. Check out our methodology now! #ATMP #pharmamanufacturing #lifescience #digitalization

We are thrilled to announce that our Epista Team will participate as a Silver Sponsor at the upcoming @Veeva Summit R&D and Quality in Boston on September 9th and 10th. 🎉 Veeva R&D and Quality Summit offers over 100 sessions across clinical, quality and manufacturing, regulatory, and safety. These include insights from pioneering industry thought leaders, panel discussions, group demos, product deep dives, innovation theaters, and peer-to-peer networking. If you are interested in scheduling a meet-up during the Summit or have any inquiries about our involvement, please reach out to Toni Lakin-Ritter or Flemming Kjoeller in advance. ✨ We’re more than excited! 🚀 #EpistaLifeScience #LifeScience #VeevaSummitBoston #VeevaPartner