At nuvalore, we collaborate with pharmaceutical and biotech teams to provide GMP-compliant analytical services for drug product and pharmaceutical development, grounded in scientific excellence, Quality by Design (QbD) <\/a>principles, and deep regulatory expertise. Our integrated approach supports your molecule through every stage \u2014 from method development and validation to stability and release testing \u2014 delivering robust, consistent data and faster progress to market.<\/p>\n<\/div>Fon<\/h5><\/div>+49 (6224) 179 966 0<\/p>\n<\/div><\/div><\/div>Mail<\/h5><\/div>info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/i><\/span>enquiry<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Analytical Method Development, Validation & Transfer Services<\/h2><\/div>At nuvalore, we provide end-to-end GMP analytical method development, validation, and transfer services aligned with ICH Q14\/Q2(R2) requirements<\/p>\n\u2014 supporting drug product development from early feasibility through full validation. Our scientists apply Quality by Design (QbD) and Design of Experiments (DoE) <\/a>principles to create phase-appropriate, robust methods that deliver consistent and reliable results.<\/p>\nFrom feasibility through inter-laboratory transfer, every step is scientifically justified, fully documented, and ready for regulatory submission.<\/p>\nThis integrated lifecycle approach minimizes variability, reduces rework, and ensures smooth method implementation \u2014 accelerating your path to regulatory approval.<\/p>\n<\/div>Explore our Method Development and Validation Services<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>Drug Characterization & Routine Analytics Services<\/h2><\/div>Nuvalore offers drug product characterization and routine analytical services to ensure product quality, stability, and regulatory readiness.<\/p>\nOur portfolio combines compendial testing with advanced analytical techniques to support every stage of drug product and pharmaceutical development.<\/p>\nOur expertise includes:<\/p>\n\nRoutine compendial testing \u2014 pH, osmolarity, clarity, subvisible particles, and extractable volume<\/li>\nChromatographic methods \u2014 Advanced HPLC-based methods are applied for structural and purity assessments:\n\n\n\nRP-HPLC and peptide mapping for identity and purity<\/li>\nIEX-UV for charge variant profiling<\/li>\nSEC SEC for aggregate detection<\/li>\nHIC-HPLC for hydrophobic interaction analysis<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\nCapillary electrophoresis (CE) \u2014 Used for high-resolution separation and characterization of proteins and charge variants<\/li>\nImaged Capillary Isoelectric Focusing (icIEF) \u2014 For separating proteins based on their isoelectric points (pI)<\/li>\nSurfactant analysis \u2014 Polysorbate 20\/80 and poloxamers are quantified using HPLC-CAD, supporting formulation stability studies<\/li>\nELISA-based assays \u2014 for binding activity testing, particularly for biologics and antibody-based products<\/li>\nDissolution and release testing \u2014 Performed on bulk materials and finished dosage forms to evaluate drug release profiles<\/li>\nForce measurement \u2014 To assess mechanical strength, activation force, and device\u2013drug performance<\/li>\n<\/ul>\nThese studies help define Critical Quality Attributes (CQAs), confirm molecular integrity, and ensure consistent performance from development through commercial release.<\/p>\n<\/div>Discover our Drug Characterization Capabilities<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Stability Testing Services<\/h2><\/div>Nuvalore delivers ICH-compliant stability studies to ensure your drug product maintains its quality, safety, and efficacy throughout its shelf life. Our tailored programs include long-term, accelerated, stress, and in-use stability testing in full alignment with ICH guidelines. From protocol design to data evaluation, we manage every step with complete traceability and regulatory confidence \u2014 providing the data you need to define shelf life, confirm storage conditions, and support GMP analytical documentation global regulatory submissions.<\/p>\n<\/div>See our Stability Testing Capabilities<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>Release Testing Services<\/h2><\/div>Nuvalore offers GMP-compliant release testing services to verify that each batch meets predefined quality specifications before market release. We perform release testing of drug substances, intermediates, and finished products using validated analytical methods and compendial procedures in accordance regulatory requirements. Our team ensures timely execution, accurate documentation, and clear data reporting to support batch certification and product approval. With precise, reliable analytics, we help our partners maintain quality consistency and ensure that every product delivered is safe and compliant.<\/p>\n<\/div>Contact us for Release Testing Support<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Consulting Services<\/h2><\/div>Nuvalore provides expert consulting services that integrates deep scientific understanding and regulatory expertise to strengthen analytical and quality programs. We partner with clients to design, implement, and refine systems that ensure GMP compliance and operational excellence \u2014 building efficient, sustainable laboratory operations aligned with global quality standards.<\/p>\nOur consulting expertise includes:<\/p>\n\nGMP implementation and laboratory qualification<\/li>\nEstablishment of Quality Management Systems (QMS)<\/li>\nAnalytical method lifecycle management and regulatory readiness<\/li>\nQualification and validation of laboratory equipment<\/li>\n<\/ul>\nWe also provide statistical experimental design (Design of Experiments, DoE) consulting in both GMP-regulated and non-GMP settings. These services enhance efficiency, reproducibility, and scientific insight in early-stage research, assay development, and exploratory studies.<\/p>\nOur DoE consulting supports:<\/p>\n\nPhD candidates and academic researchers conducting complex cell-culture or assay-optimization studies<\/li>\nBiotech innovators refining ligand-binding assays or formulation development<\/li>\nLaboratories seeking reproducible, data-driven experimental strategies<\/li>\n<\/ul>\nAt nuvalore, we approach every project as a collaborative partnership \u2014 helping clients implement sustainable improvements that enhance decision-making, accelerate development, and maintain compliance from early research through commercialization.<\/p>\n<\/div>Connect with our Experts for Consulting Guidance<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>nuvalore GmbH<\/strong>\nPaul-Ehrlich-Str. 1\nD – 69181 Leimen<\/p>\n<\/div><\/div><\/div>Fon<\/h5><\/div>+49 (6224) 179 966 0<\/p>\n<\/div><\/div><\/div>Mail<\/h5><\/div>info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-7437","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/comments?post=7437"}],"version-history":[{"count":10,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions"}],"predecessor-version":[{"id":7596,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions\/7596"}],"wp:attachment":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/media?parent=7437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
+49 (6224) 179 966 0<\/p>\n<\/div><\/div><\/div>
info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/i><\/span>enquiry<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Analytical Method Development, Validation & Transfer Services<\/h2><\/div>At nuvalore, we provide end-to-end GMP analytical method development, validation, and transfer services aligned with ICH Q14\/Q2(R2) requirements<\/p>\n\u2014 supporting drug product development from early feasibility through full validation. Our scientists apply Quality by Design (QbD) and Design of Experiments (DoE) <\/a>principles to create phase-appropriate, robust methods that deliver consistent and reliable results.<\/p>\nFrom feasibility through inter-laboratory transfer, every step is scientifically justified, fully documented, and ready for regulatory submission.<\/p>\nThis integrated lifecycle approach minimizes variability, reduces rework, and ensures smooth method implementation \u2014 accelerating your path to regulatory approval.<\/p>\n<\/div>Explore our Method Development and Validation Services<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>Drug Characterization & Routine Analytics Services<\/h2><\/div>Nuvalore offers drug product characterization and routine analytical services to ensure product quality, stability, and regulatory readiness.<\/p>\nOur portfolio combines compendial testing with advanced analytical techniques to support every stage of drug product and pharmaceutical development.<\/p>\nOur expertise includes:<\/p>\n\nRoutine compendial testing \u2014 pH, osmolarity, clarity, subvisible particles, and extractable volume<\/li>\nChromatographic methods \u2014 Advanced HPLC-based methods are applied for structural and purity assessments:\n\n\n\nRP-HPLC and peptide mapping for identity and purity<\/li>\nIEX-UV for charge variant profiling<\/li>\nSEC SEC for aggregate detection<\/li>\nHIC-HPLC for hydrophobic interaction analysis<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\nCapillary electrophoresis (CE) \u2014 Used for high-resolution separation and characterization of proteins and charge variants<\/li>\nImaged Capillary Isoelectric Focusing (icIEF) \u2014 For separating proteins based on their isoelectric points (pI)<\/li>\nSurfactant analysis \u2014 Polysorbate 20\/80 and poloxamers are quantified using HPLC-CAD, supporting formulation stability studies<\/li>\nELISA-based assays \u2014 for binding activity testing, particularly for biologics and antibody-based products<\/li>\nDissolution and release testing \u2014 Performed on bulk materials and finished dosage forms to evaluate drug release profiles<\/li>\nForce measurement \u2014 To assess mechanical strength, activation force, and device\u2013drug performance<\/li>\n<\/ul>\nThese studies help define Critical Quality Attributes (CQAs), confirm molecular integrity, and ensure consistent performance from development through commercial release.<\/p>\n<\/div>Discover our Drug Characterization Capabilities<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Stability Testing Services<\/h2><\/div>Nuvalore delivers ICH-compliant stability studies to ensure your drug product maintains its quality, safety, and efficacy throughout its shelf life. Our tailored programs include long-term, accelerated, stress, and in-use stability testing in full alignment with ICH guidelines. From protocol design to data evaluation, we manage every step with complete traceability and regulatory confidence \u2014 providing the data you need to define shelf life, confirm storage conditions, and support GMP analytical documentation global regulatory submissions.<\/p>\n<\/div>See our Stability Testing Capabilities<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>Release Testing Services<\/h2><\/div>Nuvalore offers GMP-compliant release testing services to verify that each batch meets predefined quality specifications before market release. We perform release testing of drug substances, intermediates, and finished products using validated analytical methods and compendial procedures in accordance regulatory requirements. Our team ensures timely execution, accurate documentation, and clear data reporting to support batch certification and product approval. With precise, reliable analytics, we help our partners maintain quality consistency and ensure that every product delivered is safe and compliant.<\/p>\n<\/div>Contact us for Release Testing Support<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Consulting Services<\/h2><\/div>Nuvalore provides expert consulting services that integrates deep scientific understanding and regulatory expertise to strengthen analytical and quality programs. We partner with clients to design, implement, and refine systems that ensure GMP compliance and operational excellence \u2014 building efficient, sustainable laboratory operations aligned with global quality standards.<\/p>\nOur consulting expertise includes:<\/p>\n\nGMP implementation and laboratory qualification<\/li>\nEstablishment of Quality Management Systems (QMS)<\/li>\nAnalytical method lifecycle management and regulatory readiness<\/li>\nQualification and validation of laboratory equipment<\/li>\n<\/ul>\nWe also provide statistical experimental design (Design of Experiments, DoE) consulting in both GMP-regulated and non-GMP settings. These services enhance efficiency, reproducibility, and scientific insight in early-stage research, assay development, and exploratory studies.<\/p>\nOur DoE consulting supports:<\/p>\n\nPhD candidates and academic researchers conducting complex cell-culture or assay-optimization studies<\/li>\nBiotech innovators refining ligand-binding assays or formulation development<\/li>\nLaboratories seeking reproducible, data-driven experimental strategies<\/li>\n<\/ul>\nAt nuvalore, we approach every project as a collaborative partnership \u2014 helping clients implement sustainable improvements that enhance decision-making, accelerate development, and maintain compliance from early research through commercialization.<\/p>\n<\/div>Connect with our Experts for Consulting Guidance<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>nuvalore GmbH<\/strong>\nPaul-Ehrlich-Str. 1\nD – 69181 Leimen<\/p>\n<\/div><\/div><\/div>Fon<\/h5><\/div>+49 (6224) 179 966 0<\/p>\n<\/div><\/div><\/div>Mail<\/h5><\/div>info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-7437","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/comments?post=7437"}],"version-history":[{"count":10,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions"}],"predecessor-version":[{"id":7596,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions\/7596"}],"wp:attachment":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/media?parent=7437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
At nuvalore, we provide end-to-end GMP analytical method development, validation, and transfer services aligned with ICH Q14\/Q2(R2) requirements<\/p>\n
\u2014 supporting drug product development from early feasibility through full validation. Our scientists apply Quality by Design (QbD) and Design of Experiments (DoE) <\/a>principles to create phase-appropriate, robust methods that deliver consistent and reliable results.<\/p>\nFrom feasibility through inter-laboratory transfer, every step is scientifically justified, fully documented, and ready for regulatory submission.<\/p>\nThis integrated lifecycle approach minimizes variability, reduces rework, and ensures smooth method implementation \u2014 accelerating your path to regulatory approval.<\/p>\n<\/div>Explore our Method Development and Validation Services<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>Drug Characterization & Routine Analytics Services<\/h2><\/div>Nuvalore offers drug product characterization and routine analytical services to ensure product quality, stability, and regulatory readiness.<\/p>\nOur portfolio combines compendial testing with advanced analytical techniques to support every stage of drug product and pharmaceutical development.<\/p>\nOur expertise includes:<\/p>\n\nRoutine compendial testing \u2014 pH, osmolarity, clarity, subvisible particles, and extractable volume<\/li>\nChromatographic methods \u2014 Advanced HPLC-based methods are applied for structural and purity assessments:\n\n\n\nRP-HPLC and peptide mapping for identity and purity<\/li>\nIEX-UV for charge variant profiling<\/li>\nSEC SEC for aggregate detection<\/li>\nHIC-HPLC for hydrophobic interaction analysis<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\nCapillary electrophoresis (CE) \u2014 Used for high-resolution separation and characterization of proteins and charge variants<\/li>\nImaged Capillary Isoelectric Focusing (icIEF) \u2014 For separating proteins based on their isoelectric points (pI)<\/li>\nSurfactant analysis \u2014 Polysorbate 20\/80 and poloxamers are quantified using HPLC-CAD, supporting formulation stability studies<\/li>\nELISA-based assays \u2014 for binding activity testing, particularly for biologics and antibody-based products<\/li>\nDissolution and release testing \u2014 Performed on bulk materials and finished dosage forms to evaluate drug release profiles<\/li>\nForce measurement \u2014 To assess mechanical strength, activation force, and device\u2013drug performance<\/li>\n<\/ul>\nThese studies help define Critical Quality Attributes (CQAs), confirm molecular integrity, and ensure consistent performance from development through commercial release.<\/p>\n<\/div>Discover our Drug Characterization Capabilities<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Stability Testing Services<\/h2><\/div>Nuvalore delivers ICH-compliant stability studies to ensure your drug product maintains its quality, safety, and efficacy throughout its shelf life. Our tailored programs include long-term, accelerated, stress, and in-use stability testing in full alignment with ICH guidelines. From protocol design to data evaluation, we manage every step with complete traceability and regulatory confidence \u2014 providing the data you need to define shelf life, confirm storage conditions, and support GMP analytical documentation global regulatory submissions.<\/p>\n<\/div>See our Stability Testing Capabilities<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>Release Testing Services<\/h2><\/div>Nuvalore offers GMP-compliant release testing services to verify that each batch meets predefined quality specifications before market release. We perform release testing of drug substances, intermediates, and finished products using validated analytical methods and compendial procedures in accordance regulatory requirements. Our team ensures timely execution, accurate documentation, and clear data reporting to support batch certification and product approval. With precise, reliable analytics, we help our partners maintain quality consistency and ensure that every product delivered is safe and compliant.<\/p>\n<\/div>Contact us for Release Testing Support<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Consulting Services<\/h2><\/div>Nuvalore provides expert consulting services that integrates deep scientific understanding and regulatory expertise to strengthen analytical and quality programs. We partner with clients to design, implement, and refine systems that ensure GMP compliance and operational excellence \u2014 building efficient, sustainable laboratory operations aligned with global quality standards.<\/p>\nOur consulting expertise includes:<\/p>\n\nGMP implementation and laboratory qualification<\/li>\nEstablishment of Quality Management Systems (QMS)<\/li>\nAnalytical method lifecycle management and regulatory readiness<\/li>\nQualification and validation of laboratory equipment<\/li>\n<\/ul>\nWe also provide statistical experimental design (Design of Experiments, DoE) consulting in both GMP-regulated and non-GMP settings. These services enhance efficiency, reproducibility, and scientific insight in early-stage research, assay development, and exploratory studies.<\/p>\nOur DoE consulting supports:<\/p>\n\nPhD candidates and academic researchers conducting complex cell-culture or assay-optimization studies<\/li>\nBiotech innovators refining ligand-binding assays or formulation development<\/li>\nLaboratories seeking reproducible, data-driven experimental strategies<\/li>\n<\/ul>\nAt nuvalore, we approach every project as a collaborative partnership \u2014 helping clients implement sustainable improvements that enhance decision-making, accelerate development, and maintain compliance from early research through commercialization.<\/p>\n<\/div>Connect with our Experts for Consulting Guidance<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div><\/div>nuvalore GmbH<\/strong>\nPaul-Ehrlich-Str. 1\nD – 69181 Leimen<\/p>\n<\/div><\/div><\/div>Fon<\/h5><\/div>+49 (6224) 179 966 0<\/p>\n<\/div><\/div><\/div>Mail<\/h5><\/div>info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-7437","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/comments?post=7437"}],"version-history":[{"count":10,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions"}],"predecessor-version":[{"id":7596,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions\/7596"}],"wp:attachment":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/media?parent=7437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
From feasibility through inter-laboratory transfer, every step is scientifically justified, fully documented, and ready for regulatory submission.<\/p>\n
This integrated lifecycle approach minimizes variability, reduces rework, and ensures smooth method implementation \u2014 accelerating your path to regulatory approval.<\/p>\n<\/div>
Nuvalore offers drug product characterization and routine analytical services to ensure product quality, stability, and regulatory readiness.<\/p>\n
Our portfolio combines compendial testing with advanced analytical techniques to support every stage of drug product and pharmaceutical development.<\/p>\n
Our expertise includes:<\/p>\n
These studies help define Critical Quality Attributes (CQAs), confirm molecular integrity, and ensure consistent performance from development through commercial release.<\/p>\n<\/div>
Nuvalore delivers ICH-compliant stability studies to ensure your drug product maintains its quality, safety, and efficacy throughout its shelf life. Our tailored programs include long-term, accelerated, stress, and in-use stability testing in full alignment with ICH guidelines. From protocol design to data evaluation, we manage every step with complete traceability and regulatory confidence \u2014 providing the data you need to define shelf life, confirm storage conditions, and support GMP analytical documentation global regulatory submissions.<\/p>\n<\/div>
Nuvalore offers GMP-compliant release testing services to verify that each batch meets predefined quality specifications before market release. We perform release testing of drug substances, intermediates, and finished products using validated analytical methods and compendial procedures in accordance regulatory requirements. Our team ensures timely execution, accurate documentation, and clear data reporting to support batch certification and product approval. With precise, reliable analytics, we help our partners maintain quality consistency and ensure that every product delivered is safe and compliant.<\/p>\n<\/div>
Nuvalore provides expert consulting services that integrates deep scientific understanding and regulatory expertise to strengthen analytical and quality programs. We partner with clients to design, implement, and refine systems that ensure GMP compliance and operational excellence \u2014 building efficient, sustainable laboratory operations aligned with global quality standards.<\/p>\n
Our consulting expertise includes:<\/p>\n
We also provide statistical experimental design (Design of Experiments, DoE) consulting in both GMP-regulated and non-GMP settings. These services enhance efficiency, reproducibility, and scientific insight in early-stage research, assay development, and exploratory studies.<\/p>\n
Our DoE consulting supports:<\/p>\n
At nuvalore, we approach every project as a collaborative partnership \u2014 helping clients implement sustainable improvements that enhance decision-making, accelerate development, and maintain compliance from early research through commercialization.<\/p>\n<\/div>
nuvalore GmbH<\/strong>\nPaul-Ehrlich-Str. 1\nD – 69181 Leimen<\/p>\n<\/div><\/div><\/div>Fon<\/h5><\/div>+49 (6224) 179 966 0<\/p>\n<\/div><\/div><\/div>Mail<\/h5><\/div>info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-7437","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/comments?post=7437"}],"version-history":[{"count":10,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions"}],"predecessor-version":[{"id":7596,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions\/7596"}],"wp:attachment":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/media?parent=7437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
info@nuvalore.com<\/a><\/p>\n<\/div><\/div><\/div>Social networks<\/h5><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"class_list":["post-7437","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/comments?post=7437"}],"version-history":[{"count":10,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions"}],"predecessor-version":[{"id":7596,"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/pages\/7437\/revisions\/7596"}],"wp:attachment":[{"href":"https:\/\/nuvalore.com\/en\/wp-json\/wp\/v2\/media?parent=7437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}