{"id":88468,"date":"2025-10-07T20:44:13","date_gmt":"2025-10-07T18:44:13","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=88468"},"modified":"2026-02-03T22:35:22","modified_gmt":"2026-02-03T21:35:22","slug":"alvotech-increases-submissions-efficiency-with-continuous-publishing","status":"publish","type":"customer-stories","link":"https:\/\/pantheon.veeva.com\/eu\/customer-stories\/alvotech-increases-submissions-efficiency-with-continuous-publishing\/","title":{"rendered":"Alvotech"},"content":{"rendered":"

\nAlvotech achieved a 40% efficiency increase by implementing Veeva Submissions Publishing<\/a> to streamline submission management. This accelerated submission processes across its product pipeline, spanning insulin and vaccines to monoclonal antibody cancer therapies. With an agile mindset, the
\nbiosimilars company went live in just 13 weeks.\n<\/p>\n

Scaling submission output ninefold<\/h2>\n

\nTo support growing submission volume, Alvotech implemented Veeva Registrations<\/a>, Veeva Submissions<\/a>, and Veeva Submissions Archive<\/a> in November 2022. However, the company maintained a traditional
\npublishing approach that did not efficiently scale with the business.\n<\/p>\n

\n\u201cThe rapid [submissions] increase highlighted the need to manage higher volume efficiently, while
\nmaintaining quality and compliance without additional resources,\u201d said Isabelle De Montazet, director of regulatory information management at Alvotech. The linear publishing process required content to be
\nfinalized and approved before being handed off to publishers. This often meant that validation errors,
\nrework, or delays surfaced late in the process, when pressure was the highest to meet submission
\ndeadlines.\n<\/p>\n

\nIn June 2024, Alvotech implemented Veeva Submissions Publishing to accelerate and scale submission output, which increased ninefold from 2020. \u201cI thought it [Veeva Submissions Publishing] was a good solution to support the submission process and financially interesting given the company\u2019s size,\u201d said De Montazet. “There were only two products to migrate at the time, with new biologic license applications (BLA) planned.” By shifting to continuous publishing on a unified RIM platform, downstream publishing and validation tasks run in parallel with upstream planning and authoring. This makes it easier for Alvotech\u2019s team to catch issues earlier in the submission lifecycle.\n<\/p>\n

Evolving roles and responsibilities for greater control<\/h2>\n

\nWith a continuous publishing approach, publishers are involved throughout the entire submission
\nlifecycle for greater visibility and control. They “have a better overview and understanding of the task
\nwhich makes more sense in the preparation of the dossier,” highlights De Montazet. This elevates the
\npublisher\u2019s role to a submission manager, responsible for document workflows as well as publishing
\ntasks. Submission managers are “more fulfilled in their daily work with greater task diversity, impact,
\nand responsibility,” adds De Montazet.\n<\/p>\n

\nSubmission managers use submission content plans (SCPs) to efficiently prepare, track, and deliver
\nsubmissions. “The submission content plan provides a visual and dynamic layout from which content
\nmanagers can easily view and update statuses, and align with continuous publishing,” says De Montazet. Leveraging eCTD expertise, submission managers can use SCP templates to include all expected
\ndocuments for a submission, even if details aren\u2019t finalized. This helps streamline downstream
\npublishing processes.\n<\/p>\n

\n“It is easier to identify the delay, adjust the timeline, and regularly update information. So we get better control from a timeline point of view,\u201d says De Montazet. “You can adapt quickly because you have a
\nclear view of your dossier at any time.”\n<\/p>\n

Accelerating submissions with continuous publishing<\/h2>\n

\nBy implementing continuous publishing, Alvotech\u2019s team submitted multiple post-approval changes and four major biologic license applications (BLAs) to the EMA, FDA, and other major markets. With 12
\nbiosimilar products in the pipeline, the company is currently working on harmonizing data across the
\nVault Platform and implementing the Veeva Quality-RIM Connection<\/a>.\n<\/p>\n

\nWith continuous publishing, Alvotech increased its efficiency by 40% year over year while using fewer
\nresources. This transformation reduced pressure on regulatory teams, increased data quality, and improved process governance. Now everyone is “always speaking about the same thing,” adds De Montazet.<\/p>\n

Learn more about continuous publishing by visiting our resource hub<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Alvotech achieved a 40% efficiency increase by implementing Veeva Submissions Publishing to streamline submission management.<\/p>\n","protected":false},"featured_media":62370,"parent":0,"template":"","product-link-list":[1441,1451,1452],"class_list":["post-88468","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-registrations","product-link-list-veeva-submissions","product-link-list-veeva-submissions-archive"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/88468"}],"collection":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":0,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/88468\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62370"}],"wp:attachment":[{"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=88468"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/pantheon.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=88468"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}