{"id":667,"date":"2022-11-23T11:33:39","date_gmt":"2022-11-23T11:33:39","guid":{"rendered":"https:\/\/operonstrategist.com\/egypt\/?page_id=667"},"modified":"2025-03-21T12:36:32","modified_gmt":"2025-03-21T12:36:32","slug":"iso-15378-consultant","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/quality-management-system\/iso-15378-consultant\/","title":{"rendered":"ISO 15378 Consultant"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"667\" class=\"elementor elementor-667\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4ca4f74c banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"4ca4f74c\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4d512ab3 exad-glass-effect-no exad-sticky-section-no\" data-id=\"4d512ab3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-79036c7d banner-sec-heading exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"79036c7d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 15378 Certification - Primary Packaging Regulatory Consulting\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5f14a8b elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"5f14a8b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-096ed16 exad-glass-effect-no exad-sticky-section-no\" data-id=\"096ed16\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-023e0b5 elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"023e0b5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a0d40bc exad-glass-effect-no exad-sticky-section-no\" data-id=\"a0d40bc\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c32b393 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"c32b393\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>ISO 15378 Certification ensures the highest quality standards for manufacturers of primary packaging materials for medicinal products, incorporating the critical ISO 15378 guidelines and Good Manufacturing Practices (GMP). At Operon Strategist, a leading medical device regulatory consultancy, we simplify the process of obtaining ISO 15378 certification, ensuring compliance with regulatory and customer requirements.<\/p><p>Introduced in 2006, the ISO 15378 standard is based on the internationally recognized ISO 9001 quality framework. It includes GMP requirements essential for primary packaging materials, such as batch tracing, risk management, validation, and controlled environments, ensuring product safety and quality.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a1a453a exad-glass-effect-no exad-sticky-section-no\" data-id=\"a1a453a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1fc7b14 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-image\" data-id=\"1fc7b14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"536\" src=\"https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2022\/11\/iso-15378_egypt-01-1024x536.jpg\" class=\"attachment-large size-large wp-image-756\" alt=\"\" srcset=\"https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2022\/11\/iso-15378_egypt-01-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2022\/11\/iso-15378_egypt-01-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2022\/11\/iso-15378_egypt-01-768x402.jpg 768w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2022\/11\/iso-15378_egypt-01-1536x804.jpg 1536w, https:\/\/operonstrategist.com\/en-eg\/wp-content\/uploads\/2022\/11\/iso-15378_egypt-01-2048x1072.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-276142d elementor-section-boxed elementor-section-height-default elementor-section-height-default exad-glass-effect-no exad-sticky-section-no\" data-id=\"276142d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-e957051 exad-glass-effect-no exad-sticky-section-no\" data-id=\"e957051\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e28fea1 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"e28fea1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2 aria-level=\"2\"><b><span data-contrast=\"none\">What is ISO 15378 QMS Certification?<\/span><\/b><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h2><p>The ISO 15378:2017 standard specifies requirements for a Quality Management System (QMS) where organizations must demonstrate their ability to consistently provide primary packaging materials for medicinal products that meet both regulatory and customer expectations. Achieving ISO 15378 certification means your company complies with international standards, bolstering your reputation and facilitating customer approvals.<\/p><p>The ISO 15378 guidelines apply to all manufacturers of packaging materials that come into direct contact with medicinal products, including glass, rubber, aluminum, and plastics. The standard is aligned with ISO 9001:2015, ensuring a comprehensive approach to quality management and GMP.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec8ff7f exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" data-id=\"ec8ff7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Key Benefits of ISO 15378 Certification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a52702d exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"a52702d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Implementing the ISO 15378 standard offers several benefits, including:<\/strong><\/p><ul><li style=\"list-style-type: none;\"><ul><li aria-level=\"1\">Reducing costs by minimizing waste and production errors while increasing efficiency.<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d5ccc48 exad-glass-effect-no exad-sticky-section-no\" data-id=\"d5ccc48\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2c0bd71 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"2c0bd71\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-279d184 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-heading\" style=\"flex-basis: var(--flex-basis); flex-grow: var(--flex-grow); flex-shrink: var(--flex-shrink); order: var(--order); align-self: var(--align-self); flex-direction: var(--flex-direction); flex-wrap: var(--flex-wrap); justify-content: var(--justify-content); align-items: var(--align-items); align-content: var(--align-content); gap: var(--gap); --swiper-theme-color: #000; --swiper-navigation-size: 44px; --swiper-pagination-bullet-size: 6px; --swiper-pagination-bullet-horizontal-gap: 6px; --widgets-spacing: 20px 20px; width: 485.375px; text-align: center; color: #000000; font-family: Poppins, sans-serif;\" data-id=\"279d184\" data-element_type=\"widget\" data-widget_type=\"heading.default\"><div class=\"elementor-widget-container\" style=\"transition: background .3s,border .3s,border-radius .3s,box-shadow .3s,transform var(--e-transform-transition-duration,.4s); margin: 0px; padding: 0px;\"><h1 class=\"elementor-heading-title elementor-size-default\" style=\"font-weight: var( --e-global-typography-primary-font-weight ); color: #212121; font-family: var( --e-global-typography-primary-font-family ), Sans-serif; -webkit-text-stroke-color: #000000; stroke: #000000;\">Looking for Consultant?<\/h1><\/div><\/div><div class=\"elementor-element elementor-element-910e680 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" style=\"flex-basis: var(--flex-basis); flex-grow: var(--flex-grow); flex-shrink: var(--flex-shrink); order: var(--order); align-self: var(--align-self); flex-direction: var(--flex-direction); flex-wrap: var(--flex-wrap); justify-content: var(--justify-content); align-items: var(--align-items); align-content: var(--align-content); column-gap: 0px; --swiper-theme-color: #000; --swiper-navigation-size: 44px; --swiper-pagination-bullet-size: 6px; --swiper-pagination-bullet-horizontal-gap: 6px; --widgets-spacing: 20px 20px; color: #bdbdbd; font-family: var( --e-global-typography-secondary-font-family ), Sans-serif; font-weight: 400; width: 485.375px; margin-bottom: 20px; margin-block-end: 20px; text-align: center;\" data-id=\"910e680\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\" style=\"transition: background .3s,border .3s,border-radius .3s,box-shadow .3s,transform var(--e-transform-transition-duration,.4s);\"><p style=\"font-size: 15px;\">Let\u2019s have word about your next project<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f286ac exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-wpforms\" data-id=\"0f286ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full\" id=\"wpforms-18\"><form id=\"wpforms-form-18\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"18\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-eg\/wp-json\/wp\/v2\/pages\/667\" data-token=\"c37150f704c0834982eec3a398f59af3\" data-token-time=\"1775640320\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div class=\"wpforms-field-container\"><div id=\"wpforms-18-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-18-field_0\">Name <span class=\"wpforms-required-label\">*<\/span><\/label><input type=\"text\" id=\"wpforms-18-field_0\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][0]\" placeholder=\"Name\" required><\/div><div id=\"wpforms-18-field_1-container\" class=\"wpforms-field wpforms-field-email\" 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value=\"Shows\/Exhibitions\"  class=\"choice-6 depth-1\"  >Shows\/Exhibitions<\/option><option value=\"Print Advertisement\"  class=\"choice-5 depth-1\"  >Print Advertisement<\/option><option value=\"Other\"  class=\"choice-4 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"18\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/667\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-18\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/en-eg\/wp-content\/plugins\/wpforms-lite\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-136f937 exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"136f937\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\">Facilitating access to new markets and encouraging international trade.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Ensuring adherence to GMP standards, reducing risks related to contamination, product mix-ups, and errors.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Enhancing product quality, thereby increasing customer satisfaction.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Providing a competitive advantage over non-certified suppliers.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Applying risk management practices to prevent errors and ensure the safety of primary packaging materials for medicinal products.<\/li><\/ul><h3><span data-contrast=\"none\">Application of ISO 15378<\/span><span data-ccp-props=\"{&quot;134245418&quot;:true,&quot;201341983&quot;:0,&quot;335559738&quot;:40,&quot;335559739&quot;:0,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h3><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">ISO 15378:2017 is an application standard for the structure, manufacture and supply of primary packaging material for medicinal products.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">It is additionally appropriate for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This primary packaging standard discovers good manufacturing practice (GMP) standards and <\/span><a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/quality-management-system\/\"><span data-contrast=\"none\">Quality Management System<\/span><\/a><span data-contrast=\"none\"> relevant to primary packaging materials for medicinal products.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">ISO 15378 can be utilized for quality improvement, training, auditing and certification.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"none\">The ISO 15378 standard is assessed every 5 years.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li><\/ul><h2><b><span data-contrast=\"none\">What will be the Role of Operon Strategist?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h2><p><span data-contrast=\"none\">Our team can perform various activities like GAP analysis, QMS implementation and others. After understanding the need of ISO 15378, by performing GAP analysis and QMS we can assist you in creation of documentation and training.<\/span><\/p><div class=\"elementor-element elementor-element-6265c20f exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-text-editor\" data-id=\"6265c20f\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p>We also provide medical device consultation for\u00a0<a href=\"https:\/\/operonstrategist.com\/\">India<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-za\/\">South Africa<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-eg\/\">Egypt,<\/a>\u00a0the\u00a0<a href=\"https:\/\/us.operonstrategist.com\/\">USA<\/a>, the\u00a0<a href=\"https:\/\/operonstrategist.com\/en-gb\/\">UK<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-cr\/\">Costa Rica<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-om\/\">Oman<\/a>, and\u00a0<a href=\"https:\/\/operonstrategist.com\/en-ir\/\">Iran.<\/a>\u00a0For free consultation\u00a0<a href=\"https:\/\/operonstrategist.com\/en-eg\/contact-us\/\">Contact us<\/a>\u00a0now.\u00a0\u00a0<\/p><\/div><\/div><div class=\"elementor-element elementor-element-1863b52b exad-sticky-section-no exad-glass-effect-no elementor-widget elementor-widget-button\" data-id=\"1863b52b\" data-element_type=\"widget\" data-widget_type=\"button.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-button-wrapper\">\u00a0<\/div><\/div><\/div><h2><b><span data-contrast=\"none\">How will Operon Strategist help you in ISO 15378?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h2><p>At Operon Strategist, we assist manufacturers of primary packaging materials for medicinal products with a full range of services, including GAP analysis, QMS implementation, and GMP compliance. Our team ensures your systems align with ISO 15378:2017 guidelines by addressing all regulatory requirements to meet quality objectives.<\/p><p>Whether you\u2019re located in \u00a0<a href=\"https:\/\/operonstrategist.com\/\">India<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-za\/\">South Africa<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-eg\/\">Egypt,<\/a> the\u00a0<a href=\"https:\/\/us.operonstrategist.com\/\">USA<\/a>, the <a href=\"https:\/\/operonstrategist.com\/en-gb\/\">UK<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-cr\/\">Costa Rica<\/a>,\u00a0<a href=\"https:\/\/operonstrategist.com\/en-om\/\">Oman<\/a>, or <a href=\"https:\/\/operonstrategist.com\/en-ir\/\">Iran<\/a><span style=\"box-sizing: border-box;\"><a href=\"https:\/\/operonstrategist.com\/en-ir\/\" target=\"_blank\" rel=\"noopener\">,<\/a> we<\/span>\u00a0provide expert consultation to help you achieve ISO 15378 certification and enhance your QMS system. <a href=\"https:\/\/operonstrategist.com\/en-eg\/contact-us\/\">Contact us<\/a> for a free consultation today.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>ISO 15378 Certification &#8211; Primary Packaging Regulatory Consulting ISO 15378 Certification ensures the highest quality standards for manufacturers of primary packaging materials for medicinal products, incorporating the critical ISO 15378 guidelines and Good Manufacturing Practices (GMP). At Operon Strategist, a leading medical device regulatory consultancy, we simplify the process of obtaining ISO 15378 certification, ensuring [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":450,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-667","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/667","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/comments?post=667"}],"version-history":[{"count":6,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/667\/revisions"}],"predecessor-version":[{"id":2365,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/667\/revisions\/2365"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/pages\/450"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-eg\/wp-json\/wp\/v2\/media?parent=667"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}