{"id":714,"date":"2026-02-03T16:26:59","date_gmt":"2026-02-03T15:26:59","guid":{"rendered":"https:\/\/madeconseil.com\/?page_id=714"},"modified":"2026-02-03T16:46:25","modified_gmt":"2026-02-03T15:46:25","slug":"our-expertises","status":"publish","type":"page","link":"https:\/\/madeconseil.com\/en\/our-expertises\/","title":{"rendered":"OUR EXPERTISES"},"content":{"rendered":"
<\/div>
<\/div>
<\/div>

\nour business
sectors\n<\/h1><\/div><\/div><\/div><\/div>

\nPharmaceutical
\n<\/h2>
\n<\/svg>\n<\/figure>
\nWe secure your projects within a demanding GxP framework, from pharmaceutical development to production operations, ensuring compliance, industrial robustness, and risk control.\n<\/div><\/div>

\nR&D & INDUSTRIAL TRANSFER\n<\/h3>
\nManagement of analytical and formulation development through to transfer into production.
Definition and control of CQAs \/ CPPs, development of VMP, PPQ, and cleaning strategies, and production of the CMC documentation required for the transition from laboratory to industrial scale.
Securing critical stages to ensure process robustness, regulatory compliance, and industrial performance.\n<\/div><\/div>

\nENGINEERING \u2022 INDUSTRIALIZATION \u2022 QUALIFICATION \/ VALIDATION
\n<\/h3>
\nManagement of industrialization projects including critical utilities, FAT \/ SAT activities, and commissioning.
Preparation and execution of DQ \/ IQ \/ OQ \/ PQ, deployment of PPQ stages, cleaning validation, and qualification of computerized systems (CSV \u2013 SCADA, BMS, MES, LIMS).
Ensuring GxP compliance and the operational performance of facilities.
\n<\/div><\/div>

\nQUALITY & REGULATORY AFFAIRS
\n<\/h3>
\nManagement of Operational Quality activities: deviations, CAPA, OOS \/ OOT.
Alignment of GxP QMS systems and Data Integrity, inspection readiness, and management of CMC documentation requirements (Module 3).
Control of regulatory risk and business continuity.
\n<\/div><\/div>

\nPROJECTS \u2022 SUPPLY \u2022 PROCUREMENT \u2022 OPERATIONAL EXCELLENCE
\n<\/h3>
\nManagement of industrial projects through structured PMOs integrating the V-cycle, ramp-up management, MRP \/ MPS planning, organization of ZAC flows, CAPEX \/ OPEX sourcing, and deployment of Lean \/ Six Sigma approaches.
\n<\/div><\/div><\/div><\/div><\/div><\/div>

\nBiotechnology
\n<\/h2>
\n<\/svg>\n<\/figure>
\nWe support the industrialization and control of bioprocesses based on living biological systems, in healthcare and demanding industrial environments.
\n<\/div><\/div>

\nR&D & INDUSTRIAL TRANSFER\n<\/h3>
\nDevelopment and optimization of living bioprocesses
(cells, fermentation, expression).
Upstream \/ downstream control, identification and management of CPP \/ CQA.
Robustness and comparability studies, scale-up \/ scale-down.
Transfer of biological processes and deployment of biotech PPQ strategies.
CMC support (Module 3) to secure the transition from clinical to commercial.\n<\/div><\/div>

\nENGINEERING \u2022 INDUSTRIALIZATION \u2022 Q\/V
\n<\/h3>
\nQualification and validation of critical bioproduction equipment
(bioreactors, skids, filtration, centrifugation, areas and utilities).
Validation of sensitive processes (cleaning, sterilization, aseptic).
Validation of computerized systems supporting bioprocesses
(MES, LIMS, eBR).
Securing the industrial reproducibility of living systems in GMP or advanced industrial environments.
\n<\/div><\/div>

\nQUALITY \u2022 ANALYTICAL \u2022 REGULATORY
\n<\/h3>
\nStructuring quality systems adapted to bioprocesses,
in demanding GxP or industrial environments.
Management of complex deviations and CAPA linked to biological variability.
Oversight of Data Integrity requirements (process and analytical data).
Biotech CMC support (process, control, stability).
Preparation for and support during inspections when applicable.
\n<\/div><\/div>

\nPROJECTS \u2022 SUPPLY \u2022 OPERATIONAL EXCELLENCE
\n<\/h3>
\nManagement of high-stakes biotech projects:
industrialization, capacity expansions, bioprocess transfers.
Coordination of CDMOs \/ industrial partners \/ critical suppliers.
Optimization of flows, equipment qualification,
digitalization of biotech operations (MES \/ LIMS).
Securing critical supplies and business continuity.\n<\/div><\/div><\/div><\/div><\/div><\/div>

\nMedical Devices\n<\/h2>
\n<\/svg>\n<\/figure>
\nWe secure your projects within a demanding GxP framework, from formulation development to production operations, ensuring compliance, industrial robustness, and risk control.\n<\/div><\/div>

\nR&D & INDUSTRIAL TRANSFER\n<\/h3>
\nManagement of activities from functional analysis through to pre-series transfer.
Definition of technical specifications, prototyping, development and execution of V&V plans, integration of DfM, and preparation of the technical elements required for regulatory submissions (CE \/ FDA 510(k)).
\n<\/div><\/div>

\nENGINEERING \u2022 INDUSTRIALIZATION \u2022 QUALIFICATION \/ VALIDATION
\n<\/h3>
\nImplementation and qualification of assembly and automation lines.
Execution of device-specific IQ \/ OQ \/ PQ for MD \/ IVD, validation of sterilization, sealing, and dosing processes, and validation of production and inspection software.
\n<\/div><\/div>

\nQUALITY & REGULATORY AFFAIRS
\n<\/h3>
\nDeployment of ISO 13485 \/ ISO 14971 standards, management of risk management, PMS, and vigilance.
Preparation of Technical Files, CE \/ FDA 510(k) submissions, supplier audits, and cleaning and performance validations.
\n<\/div><\/div>

\nPROJECTS \u2022 SUPPLY \u2022 PROCUREMENT \u2022 OPERATIONAL EXCELLENCE
\n<\/h3>
\nManagement of MD \/ IVD projects: industrial transfers, serial production lines, Quality \/ RA PMO.
Management of sterile flows and cleanrooms, transport qualification, sourcing of critical components, Lean initiatives, and quality digitalization.\n<\/div><\/div><\/div><\/div><\/div><\/div>

\nCosmetics\n<\/h2>
\n<\/svg>\n<\/figure>
\nWe secure your projects within a demanding GxP framework, from formulation development to production operations, ensuring compliance, industrial robustness, and risk control.
\n<\/div><\/div>

\nR&D & INDUSTRIAL TRANSFER\n<\/h3>
\nSupport for the transition from formulation to pilot to industrial scale.
Conducting stability studies, compliance and safety testing, defining process parameters and packaging constraints, and preparation of the cosmetic technical file.\n<\/div><\/div>

\nENGINEERING \u2022 INDUSTRIALIZATION \u2022 QUALIFICATION \/ VALIDATION\n<\/h3>
\nIndustrialization and qualification of formulation equipment and packaging lines.
Implementation of IQ \/ OQ \/ PQ, cleaning validation, and optimization of process parameters (mixing, viscosity).\n<\/div><\/div>

\nQUALITY & REGULATORY AFFAIRS\n<\/h3>
\nApplication of ISO 22716 requirements.
Control of raw materials and packaging, internal and supplier audits, preparation of the Product Information File, and verification of regulatory claim compliance.\n<\/div><\/div>

\nPROJECTS \u2022 SUPPLY \u2022 PROCUREMENT \u2022 OPERATIONAL EXCELLENCE\n<\/h3>
\nStructuring projects from formulation through to production.
Management of range launches and format changes, sourcing of raw materials and packaging, procurement of packaging and actives, improvement of line OEE, and flow standardization.\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div>

\nBOOK A MEETING\n<\/h2>
\nAGENDA\n<\/a><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"

our businesssectors Pharmaceutical We secure your projects within a demanding GxP framework, from pharmaceutical development to production operations, ensuring compliance, industrial robustness, and risk control. R&D & INDUSTRIAL TRANSFER Management of analytical and formulation development through to transfer into production.Definition and control of CQAs \/ CPPs, development of VMP, PPQ, and cleaning strategies, and production […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_oxygen_hide_in_design_set":false,"_oxygen_tags":"","footnotes":""},"class_list":["post-714","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nOur expertise \u2013 Engineering, quality, and projects in healthcare<\/title>\n<meta name=\"description\" content=\"Discover our expertise in pharmaceuticals, biotechnology, medical devices, and cosmetics: engineering, quality, industrialization, and healthcare project management.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/madeconseil.com\/en\/our-expertises\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Our expertise \u2013 Engineering, quality, and projects in healthcare\" \/>\n<meta property=\"og:description\" content=\"Discover our expertise in pharmaceuticals, biotechnology, medical devices, and cosmetics: engineering, quality, industrialization, and healthcare project management.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/madeconseil.com\/en\/our-expertises\/\" \/>\n<meta property=\"og:site_name\" content=\"Made Conseil\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-03T15:46:25+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/madeconseil.com\/en\/our-expertises\/\",\"url\":\"https:\/\/madeconseil.com\/en\/our-expertises\/\",\"name\":\"Our expertise \u2013 Engineering, quality, and projects in healthcare\",\"isPartOf\":{\"@id\":\"https:\/\/madeconseil.com\/en\/#website\"},\"datePublished\":\"2026-02-03T15:26:59+00:00\",\"dateModified\":\"2026-02-03T15:46:25+00:00\",\"description\":\"Discover our expertise in pharmaceuticals, biotechnology, medical devices, and cosmetics: engineering, quality, industrialization, and healthcare project management.\",\"breadcrumb\":{\"@id\":\"https:\/\/madeconseil.com\/en\/our-expertises\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/madeconseil.com\/en\/our-expertises\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/madeconseil.com\/en\/our-expertises\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Accueil\",\"item\":\"https:\/\/madeconseil.com\/en\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"OUR EXPERTISES\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/madeconseil.com\/en\/#website\",\"url\":\"https:\/\/madeconseil.com\/en\/\",\"name\":\"Made Conseil\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/madeconseil.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/madeconseil.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-GB\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/madeconseil.com\/en\/#organization\",\"name\":\"Made Conseil\",\"url\":\"https:\/\/madeconseil.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\/\/madeconseil.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/madeconseil.com\/wp-content\/uploads\/2026\/01\/cropped-favicon-made.webp\",\"contentUrl\":\"https:\/\/madeconseil.com\/wp-content\/uploads\/2026\/01\/cropped-favicon-made.webp\",\"width\":512,\"height\":512,\"caption\":\"Made Conseil\"},\"image\":{\"@id\":\"https:\/\/madeconseil.com\/en\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Our expertise \u2013 Engineering, quality, and projects in healthcare","description":"Discover our expertise in pharmaceuticals, biotechnology, medical devices, and cosmetics: engineering, quality, industrialization, and healthcare project management.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/madeconseil.com\/en\/our-expertises\/","og_locale":"en_GB","og_type":"article","og_title":"Our expertise \u2013 Engineering, quality, and projects in healthcare","og_description":"Discover our expertise in pharmaceuticals, biotechnology, medical devices, and cosmetics: engineering, quality, industrialization, and healthcare project management.","og_url":"https:\/\/madeconseil.com\/en\/our-expertises\/","og_site_name":"Made Conseil","article_modified_time":"2026-02-03T15:46:25+00:00","twitter_card":"summary_large_image","twitter_misc":{"Estimated reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/madeconseil.com\/en\/our-expertises\/","url":"https:\/\/madeconseil.com\/en\/our-expertises\/","name":"Our expertise \u2013 Engineering, quality, and projects in healthcare","isPartOf":{"@id":"https:\/\/madeconseil.com\/en\/#website"},"datePublished":"2026-02-03T15:26:59+00:00","dateModified":"2026-02-03T15:46:25+00:00","description":"Discover our expertise in pharmaceuticals, biotechnology, medical devices, and cosmetics: engineering, quality, industrialization, and healthcare project management.","breadcrumb":{"@id":"https:\/\/madeconseil.com\/en\/our-expertises\/#breadcrumb"},"inLanguage":"en-GB","potentialAction":[{"@type":"ReadAction","target":["https:\/\/madeconseil.com\/en\/our-expertises\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/madeconseil.com\/en\/our-expertises\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Accueil","item":"https:\/\/madeconseil.com\/en\/home\/"},{"@type":"ListItem","position":2,"name":"OUR EXPERTISES"}]},{"@type":"WebSite","@id":"https:\/\/madeconseil.com\/en\/#website","url":"https:\/\/madeconseil.com\/en\/","name":"Made Conseil","description":"","publisher":{"@id":"https:\/\/madeconseil.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/madeconseil.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-GB"},{"@type":"Organization","@id":"https:\/\/madeconseil.com\/en\/#organization","name":"Made Conseil","url":"https:\/\/madeconseil.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/madeconseil.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/madeconseil.com\/wp-content\/uploads\/2026\/01\/cropped-favicon-made.webp","contentUrl":"https:\/\/madeconseil.com\/wp-content\/uploads\/2026\/01\/cropped-favicon-made.webp","width":512,"height":512,"caption":"Made Conseil"},"image":{"@id":"https:\/\/madeconseil.com\/en\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/pages\/714","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/comments?post=714"}],"version-history":[{"count":14,"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/pages\/714\/revisions"}],"predecessor-version":[{"id":733,"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/pages\/714\/revisions\/733"}],"wp:attachment":[{"href":"https:\/\/madeconseil.com\/en\/wp-json\/wp\/v2\/media?parent=714"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}