{"id":6775,"date":"2025-12-13T07:44:14","date_gmt":"2025-12-13T06:44:14","guid":{"rendered":"https:\/\/qp-eng.de\/?post_type=avada_faq&#038;p=6775"},"modified":"2025-12-13T07:45:10","modified_gmt":"2025-12-13T06:45:10","slug":"wann-braucht-ein-unternehmen-pharma-consulting","status":"publish","type":"avada_faq","link":"https:\/\/qp-eng.de\/en\/faq-items\/wann-braucht-ein-unternehmen-pharma-consulting\/","title":{"rendered":"When does a company need pharma consulting?"},"content":{"rendered":"<p>Pharma consulting becomes a decisive success factor in a range of situations. Typical reasons for bringing in external GMP advice are:<\/p>\n<ul>\n<li class=\"translation-block\"><b>Preparing for regulatory inspections<\/b>: An audit by an authority such as the Regierungspr\u00e4sidium or the FDA is on the way, and you want every process and document to meet the requirements.<\/li>\n<li class=\"translation-block\"><b>Building new production facilities<\/b>: When you are planning new manufacturing sites and want to build and qualify them GMP-compliantly from the outset.<\/li>\n<li class=\"translation-block\"><b>Staffing shortfalls in quality<\/b>: When your QA\/QC department is overloaded, or key positions such as the Qualified Person need to be filled temporarily.<\/li>\n<li class=\"translation-block\"><b>Introducing new products or processes<\/b>: When new medicinal products, dosage forms, or manufacturing methods need to be validated and integrated into existing systems.<\/li>\n<li class=\"translation-block\"><b>Closing compliance deviations<\/b>: When findings from audits or self-inspections need to be remediated quickly and properly.<\/li>\n<li class=\"translation-block\"><b>Adapting to new regulations<\/b>: When regulatory changes such as the EU GMP Annex 1 revision 2022 call for a rework of your processes and documentation.<\/li>\n<li class=\"translation-block\"><b>A first manufacturing authorisation<\/b>: When start-ups or scale-ups are building their first GMP operation and applying for a manufacturing authorisation under \u00a7 13 AMG.<\/li>\n<\/ul>\n<p>Pharma consulting thus supports the quality assurance of your products and regulatory compliance, while strengthening customer trust and promoting the long-term success of your business.<\/p>","protected":false},"excerpt":{"rendered":"<p> [&#8230;]<\/p>\n","protected":false},"author":4,"featured_media":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"faq_category":[271],"class_list":["post-6775","avada_faq","type-avada_faq","status-publish","format-standard","hentry","faq_category-pharma-consulting"],"_links":{"self":[{"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/avada_faq\/6775","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/avada_faq"}],"about":[{"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/types\/avada_faq"}],"author":[{"embeddable":true,"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/comments?post=6775"}],"version-history":[{"count":1,"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/avada_faq\/6775\/revisions"}],"predecessor-version":[{"id":6776,"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/avada_faq\/6775\/revisions\/6776"}],"wp:attachment":[{"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/media?parent=6775"}],"wp:term":[{"taxonomy":"faq_category","embeddable":true,"href":"https:\/\/qp-eng.de\/en\/wp-json\/wp\/v2\/faq_category?post=6775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}