best-practices

best-practicesFDATools2023-09-26T17:19:00+00:00

GxP Assessments

DMAIC assessment of Quality Systems, Clinical Research Processes and Design Control Processes.

Combining a best practice frame of reference based on extensive benchmarking with objective assessment and scoring methodology uniquely delivers recommendations resulting in strategic plans driving best in class process performance.

Our team is comprised of seasoned medical professionals, ex-FDA inspectors, and Fortune 500 Quality, Regulatory, and Compliance executive managers, we bring over 85 years of combined experience to the table. Our expertise spans clinical research, design controls, and manufacturing quality systems, catering to organizations ranging from small startups to Fortune 50 organizations including contract manufacturers and in-house producers.

We’re proud to be established authors for PharmaVoice, Pharma Online, Pharmaceutical Engineering, Medical Device and Diagnostics, and the Drug Information Association. Our commitment to process excellence is underscored by our commitment to industry best practices monitoring/reporting and active participation in the ASQ and RAPS communities. Recognized by Fortune 500 companies for our innovative approaches in quality management systems design, evaluation, and improvement, we remain dedicated to advancing quality and compliance in the Life Science industry.

Learn More

Podcast Participation

Insider Intelligence

Device GMP

Pharmaceutical GMP

Strategic Partnerships

contact us today

ul.filebird-block-filebird-gallery{margin:auto !important;padding:0 !important;width:100%;}ul.filebird-block-filebird-gallery.layout-grid{display:grid;grid-gap:20px;align-items:stretch;grid-template-columns:repeat(var(--columns),1fr);justify-items:stretch;}ul.filebird-block-filebird-gallery.layout-grid li img{border:1px solid #ccc;box-shadow:2px 2px 6px 0 rgba(0,0,0,.3);height:100%;max-width:100%;-o-object-fit:cover;object-fit:cover;width:100%;}ul.filebird-block-filebird-gallery.layout-masonry{-moz-column-count:var(--columns);-moz-column-gap:var(--space);column-gap:var(--space);-moz-column-width:var(--min-width);columns:var(--min-width) var(--columns);display:block;overflow:auto;}ul.filebird-block-filebird-gallery.layout-masonry li{margin-bottom:var(--space);}ul.filebird-block-filebird-gallery li{list-style:none;}ul.filebird-block-filebird-gallery li figure{height:100%;margin:0;padding:0;position:relative;width:100%;}ul.filebird-block-filebird-gallery li figure figcaption{background:linear-gradient(0deg,rgba(0,0,0,.7),rgba(0,0,0,.3) 70%,transparent);bottom:0;box-sizing:border-box;color:#fff;font-size:.8em;margin:0;max-height:100%;overflow:auto;padding:3em .77em .7em;position:absolute;text-align:center;width:100%;z-index:2;}ul.filebird-block-filebird-gallery li figure figcaption a{color:inherit;}:root{--struninnyoutube-global-primary-color:#ff3d55;--struninnyoutube-text-primary-color:#1f1f23;--struninnyoutube-text-bold-color:#1f1f23;--struninnyoutube-icon-arrow-color:#1f1f23;--struninnyoutube-overlay-color:#1b1b29;--struninnyoutube-overlay-hover-color:#ff1955;--struninnyoutube-overlay-text-color:#fff;}.woocommerce form .form-row .required{visibility:visible;}@media screen and (max-width: 640px){.fusion-no-small-visibility{display:none !important;}body .sm-text-align-center{text-align:center !important;}body .sm-text-align-left{text-align:left !important;}body .sm-text-align-right{text-align:right !important;}body .sm-flex-align-center{justify-content:center !important;}body .sm-flex-align-flex-start{justify-content:flex-start !important;}body .sm-flex-align-flex-end{justify-content:flex-end !important;}body .sm-mx-auto{margin-left:auto !important;margin-right:auto !important;}body .sm-ml-auto{margin-left:auto !important;}body .sm-mr-auto{margin-right:auto !important;}body .fusion-absolute-position-small{position:absolute;top:auto;width:100%;}.awb-sticky.awb-sticky-small{position:sticky;top:var(--awb-sticky-offset,0);}}@media screen and (min-width: 641px) and (max-width: 1024px){.fusion-no-medium-visibility{display:none !important;}body .md-text-align-center{text-align:center !important;}body .md-text-align-left{text-align:left !important;}body .md-text-align-right{text-align:right !important;}body .md-flex-align-center{justify-content:center !important;}body .md-flex-align-flex-start{justify-content:flex-start !important;}body .md-flex-align-flex-end{justify-content:flex-end !important;}body .md-mx-auto{margin-left:auto !important;margin-right:auto !important;}body .md-ml-auto{margin-left:auto !important;}body .md-mr-auto{margin-right:auto !important;}body .fusion-absolute-position-medium{position:absolute;top:auto;width:100%;}.awb-sticky.awb-sticky-medium{position:sticky;top:var(--awb-sticky-offset,0);}}@media screen and (min-width: 1025px){.fusion-no-large-visibility{display:none !important;}body .lg-text-align-center{text-align:center !important;}body .lg-text-align-left{text-align:left !important;}body .lg-text-align-right{text-align:right !important;}body .lg-flex-align-center{justify-content:center !important;}body .lg-flex-align-flex-start{justify-content:flex-start !important;}body .lg-flex-align-flex-end{justify-content:flex-end !important;}body .lg-mx-auto{margin-left:auto !important;margin-right:auto !important;}body .lg-ml-auto{margin-left:auto !important;}body .lg-mr-auto{margin-right:auto !important;}body .fusion-absolute-position-large{position:absolute;top:auto;width:100%;}.awb-sticky.awb-sticky-large{position:sticky;top:var(--awb-sticky-offset,0);}}.reading-box-container-1 .element-bottomshadow:before,.reading-box-container-1 .element-bottomshadow:after{opacity:.7;}#single,#ct-ultimate-gdpr-cookie-modal-body h1,#ct-ultimate-gdpr-cookie-modal-body h2,#ct-ultimate-gdpr-cookie-modal-body h3,#ct-ultimate-gdpr-cookie-modal-body h4,#ct-ultimate-gdpr-cookie-modal-body h5,#ct-ultimate-gdpr-cookie-modal-body h6{color:#595959;}

best-practices

GxP Assessments

DMAIC assessment of Quality Systems, Clinical Research Processes and Design Control Processes.

Combining a best practice frame of reference based on extensive benchmarking with objective assessment and scoring methodology uniquely delivers recommendations resulting in strategic plans driving best in class process performance.

Find us on Facebook

contact us today

Privacy settings

With the slider, you can enable or disable different types of cookies:

This website will:

This website won\'t: