{"id":16,"date":"2020-02-03T13:29:14","date_gmt":"2020-02-03T13:29:14","guid":{"rendered":"https:\/\/www.almacgroup.com\/analytical-solid-state\/?page_id=16"},"modified":"2025-10-01T08:55:00","modified_gmt":"2025-10-01T07:55:00","slug":"analytical-method-development-and-validation","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/analytical-solid-state\/analytical-method-development-and-validation\/","title":{"rendered":"Method Development and Validation"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\" id=\"h-developing-and-validating-more-than-300-drug-substances-and-drug-product-methods-each-year\">Developing and validating more than 300 drug substances and drug product methods each year<\/h3>\n\n\n\n<p>Analytical method development and validation is an essential part of the drug development process to ensure the methods are well defined and fit-for-purpose, and the results generated are robust and reliable and that the drug characteristics are in accordance with industry guidelines to allow progression to the next development milestone.<\/p>\n\n\n\n<p>Almac has considerable experience which, coupled with advanced instrumentation, enables the development and validation of efficient, accurate, reliable and robust analytical methods.<\/p>\n\n\n\n<p><strong>Method Development &nbsp;<\/strong><\/p>\n\n\n\n<p>Our highly skilled method development scientists have acquired years of experience, working across many types of products, methods and analytical technologies to ensure a successful outcome. Utilising laboratories equipped with sophisticated <a rel=\"noreferrer noopener\" href=\"https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/AS-Equipment-List.pdf\" target=\"_blank\">analytical instrumentation<\/a>, we can develop analytical methods suitable for all your needs.<\/p>\n\n\n\n<p><strong>Method Validation<\/strong><\/p>\n\n\n\n<p>The Almac analytical team have a comprehensive working knowledge of analytical method validation requirements that can be tailored to different phases of clinical development. To ensure methods meet regulatory requirements we follow relevant ICH guidelines such as ICH Q2(R1) or compendial guidance in combination with client-specific protocols.&nbsp;Comprehensive reports are provided upon completion.<\/p>\n\n\n\t<article class=\"o-grid o-grid--full\">\n\n\t\t<div class=\"o-grid__item u-width-full u-m-t6 u-m-t4@m u-m-b4\">\n\t\t\t<h2 class=\"u-normal u-a-center\">Related Resources<\/h2>\n\t\t<\/div>\n\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-news-panels__slider js-news-panels\">\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2024\/09\/Almac_Analytical_Equipment_List.pdf\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/4.jpeg&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Analytical Equipment List<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Analytical Equipment List<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/wp-content\/uploads\/sites\/10\/2021\/01\/Bioanalytical-Method-Validation-FDA-EMA-perspectives-V4-2.pdf\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/Bioanalytical-Method-Validation.jpeg&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Almac Voice<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Bioanalytical Method Validation &#8211; FDA &#038; EMA perspectives <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/outsourcing-analytical-services-because-its-worth-it\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/08\/SI-KC-image-1.png&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Article<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Outsourcing analytical services&#8230;because it&#8217;s worth it<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/analytical-method-development-for-synthetic-peptide-for-purity-and-impurities-content-by-uhplc\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2023\/09\/Peptides.png&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Case Study<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Analytical method development for synthetic peptide for purity and impurities content by UHPLC<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\n\n<!-- <article id=\"related\">\n\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full u-a-center\">\n\t\t\t\t\t\t\t<h3 class=\"u-normal u-m-b4\">Related Resources<\/h3>\n\t\t\t\t\t<\/div>\n\t\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-resources__slider 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href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/outsourcing-analytical-services-because-its-worth-it\/\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/08\/SI-KC-image-1.png&#039;)\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">Article<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">Outsourcing analytical services...because it's worth it<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-1\/4 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/analytical-method-development-for-synthetic-peptide-for-purity-and-impurities-content-by-uhplc\/\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2023\/09\/Peptides.png&#039;)\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">Case Study<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">Analytical method development for synthetic peptide for purity and impurities content by UHPLC<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/article> -->\n","protected":false},"excerpt":{"rendered":"<p>Developing and validating more than 300 drug substances and drug product methods each year Analytical method development and validation is an essential part of the drug development process to ensure the methods are well defined and fit-for-purpose, and the results generated are robust and reliable and that the drug characteristics are in accordance with industry [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-16","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Method Development and Validation - Analytical &amp; Solid State Services | Almac Group<\/title>\n<meta name=\"description\" content=\"Almac Analytical Method Development and Validation | Developing and validating 300 drug substances and drug product methods each year\" \/>\n<meta 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