Listing Page

Tag: FDA

What You Need to Know About Post-Approval Change Pathways

April 01, 2023

Post-approval changes (PACs) – changes made to the drug substance manufacturing process after receiving...

Why a CDMO Might Be the Best Place to Find Regulatory Support

May 02, 2021

The main goal for any drug company is achieving a speedy path to market. While many obstacles threaten...

2 Key Factors to Accelerate Drug Approvals: Expertise and Relationships

December 29, 2020

Drug approvals are often complex and time-consuming, even for generic versions of approved medications....

How to Stay Compliant in a Changing Pharma Regulatory Landscape

December 06, 2019

In 2012, contaminated medications from the New England Compounding Center (NECC) caused a meningitis...

LGM Pharma Expands Client Service Offerings Supporting The Provision of High Quality Active Pharmaceutical Ingredients (APIs) For 503B Outsourcing Facilities

June 23, 2019

Erlanger, Kentucky, June 24, 2019 – LGM Pharma, LLC, a leader in Active Pharmaceutical Ingredient (API)...

img.wp-smiley,img.emoji{display:inline !important;border:none !important;box-shadow:none !important;height:1em !important;width:1em !important;margin:0 .07em !important;vertical-align:-.1em !important;background:none !important;padding:0 !important;}body{--wp--preset--color--black:#000;--wp--preset--color--cyan-bluish-gray:#abb8c3;--wp--preset--color--white:#fff;--wp--preset--color--pale-pink:#f78da7;--wp--preset--color--vivid-red:#cf2e2e;--wp--preset--color--luminous-vivid-orange:#ff6900;--wp--preset--color--luminous-vivid-amber:#fcb900;--wp--preset--color--light-green-cyan:#7bdcb5;--wp--preset--color--vivid-green-cyan:#00d084;--wp--preset--color--pale-cyan-blue:#8ed1fc;--wp--preset--color--vivid-cyan-blue:#0693e3;--wp--preset--color--vivid-purple:#9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple:linear-gradient(135deg,rgba(6,147,227,1) 0%,#9b51e0 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan:linear-gradient(135deg,#7adcb4 0%,#00d082 100%);--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange:linear-gradient(135deg,rgba(252,185,0,1) 0%,rgba(255,105,0,1) 100%);--wp--preset--gradient--luminous-vivid-orange-to-vivid-red:linear-gradient(135deg,rgba(255,105,0,1) 0%,#cf2e2e 100%);--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray:linear-gradient(135deg,#eee 0%,#a9b8c3 100%);--wp--preset--gradient--cool-to-warm-spectrum:linear-gradient(135deg,#4aeadc 0%,#9778d1 20%,#cf2aba 40%,#ee2c82 60%,#fb6962 80%,#fef84c 100%);--wp--preset--gradient--blush-light-purple:linear-gradient(135deg,#ffceec 0%,#9896f0 100%);--wp--preset--gradient--blush-bordeaux:linear-gradient(135deg,#fecda5 0%,#fe2d2d 50%,#6b003e 100%);--wp--preset--gradient--luminous-dusk:linear-gradient(135deg,#ffcb70 0%,#c751c0 50%,#4158d0 100%);--wp--preset--gradient--pale-ocean:linear-gradient(135deg,#fff5cb 0%,#b6e3d4 50%,#33a7b5 100%);--wp--preset--gradient--electric-grass:linear-gradient(135deg,#caf880 0%,#71ce7e 100%);--wp--preset--gradient--midnight:linear-gradient(135deg,#020381 0%,#2874fc 100%);--wp--preset--duotone--dark-grayscale:url("#wp-duotone-dark-grayscale");--wp--preset--duotone--grayscale:url("#wp-duotone-grayscale");--wp--preset--duotone--purple-yellow:url("#wp-duotone-purple-yellow");--wp--preset--duotone--blue-red:url("#wp-duotone-blue-red");--wp--preset--duotone--midnight:url("#wp-duotone-midnight");--wp--preset--duotone--magenta-yellow:url("#wp-duotone-magenta-yellow");--wp--preset--duotone--purple-green:url("#wp-duotone-purple-green");--wp--preset--duotone--blue-orange:url("#wp-duotone-blue-orange");--wp--preset--font-size--small:13px;--wp--preset--font-size--medium:20px;--wp--preset--font-size--large:36px;--wp--preset--font-size--x-large:42px;--wp--preset--spacing--20:.44rem;--wp--preset--spacing--30:.67rem;--wp--preset--spacing--40:1rem;--wp--preset--spacing--50:1.5rem;--wp--preset--spacing--60:2.25rem;--wp--preset--spacing--70:3.38rem;--wp--preset--spacing--80:5.06rem;--wp--preset--shadow--natural:6px 6px 9px rgba(0,0,0,.2);--wp--preset--shadow--deep:12px 12px 50px rgba(0,0,0,.4);--wp--preset--shadow--sharp:6px 6px 0px rgba(0,0,0,.2);--wp--preset--shadow--outlined:6px 6px 0px -3px rgba(255,255,255,1),6px 6px rgba(0,0,0,1);--wp--preset--shadow--crisp:6px 6px 0px rgba(0,0,0,1);}:where(.is-layout-flex){gap:.5em;}body .is-layout-flow > .alignleft{float:left;margin-inline-start:0;margin-inline-end:2em;}body .is-layout-flow > .alignright{float:right;margin-inline-start:2em;margin-inline-end:0;}body .is-layout-flow > .aligncenter{margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > .alignleft{float:left;margin-inline-start:0;margin-inline-end:2em;}body .is-layout-constrained > .alignright{float:right;margin-inline-start:2em;margin-inline-end:0;}body .is-layout-constrained > .aligncenter{margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > :where(:not(.alignleft):not(.alignright):not(.alignfull)){max-width:var(--wp--style--global--content-size);margin-left:auto !important;margin-right:auto !important;}body .is-layout-constrained > .alignwide{max-width:var(--wp--style--global--wide-size);}body .is-layout-flex{display:flex;}body .is-layout-flex{flex-wrap:wrap;align-items:center;}body .is-layout-flex > *{margin:0;}:where(.wp-block-columns.is-layout-flex){gap:2em;}.has-black-color{color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-color{color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-color{color:var(--wp--preset--color--white) !important;}.has-pale-pink-color{color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-color{color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-color{color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-color{color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-color{color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-color{color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-color{color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-color{color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-color{color:var(--wp--preset--color--vivid-purple) !important;}.has-black-background-color{background-color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color:var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color:var(--wp--preset--color--vivid-purple) !important;}.has-black-border-color{border-color:var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color:var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color:var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color:var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color:var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color:var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color:var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color:var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color:var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color:var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color:var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color:var(--wp--preset--color--vivid-purple) !important;}.has-vivid-cyan-blue-to-vivid-purple-gradient-background{background:var(--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple) !important;}.has-light-green-cyan-to-vivid-green-cyan-gradient-background{background:var(--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan) !important;}.has-luminous-vivid-amber-to-luminous-vivid-orange-gradient-background{background:var(--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange) !important;}.has-luminous-vivid-orange-to-vivid-red-gradient-background{background:var(--wp--preset--gradient--luminous-vivid-orange-to-vivid-red) !important;}.has-very-light-gray-to-cyan-bluish-gray-gradient-background{background:var(--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray) !important;}.has-cool-to-warm-spectrum-gradient-background{background:var(--wp--preset--gradient--cool-to-warm-spectrum) !important;}.has-blush-light-purple-gradient-background{background:var(--wp--preset--gradient--blush-light-purple) !important;}.has-blush-bordeaux-gradient-background{background:var(--wp--preset--gradient--blush-bordeaux) !important;}.has-luminous-dusk-gradient-background{background:var(--wp--preset--gradient--luminous-dusk) !important;}.has-pale-ocean-gradient-background{background:var(--wp--preset--gradient--pale-ocean) !important;}.has-electric-grass-gradient-background{background:var(--wp--preset--gradient--electric-grass) !important;}.has-midnight-gradient-background{background:var(--wp--preset--gradient--midnight) !important;}.has-small-font-size{font-size:var(--wp--preset--font-size--small) !important;}.has-medium-font-size{font-size:var(--wp--preset--font-size--medium) !important;}.has-large-font-size{font-size:var(--wp--preset--font-size--large) !important;}.has-x-large-font-size{font-size:var(--wp--preset--font-size--x-large) !important;}.wp-block-navigation a:where(:not(.wp-element-button)){color:inherit;}:where(.wp-block-columns.is-layout-flex){gap:2em;}.wp-block-pullquote{font-size:1.5em;line-height:1.6;}.woocommerce form .form-row .required{visibility:visible;}.asp_m{height:0;}#uc_LGM_post_grid_elementor_28365747.uc_post_grid_style_one .uc_post_grid_style_one_wrap{grid-template-columns:repeat(3,1fr);display:grid;}#uc_LGM_post_grid_elementor_28365747 .uc_post_grid_style_one_item{overflow:hidden;position:relative;}#uc_LGM_post_grid_elementor_28365747 .lgm-ue-post-image{border-bottom:solid 1px #e0e1e2;}#uc_LGM_post_grid_elementor_28365747 .uc_more_btn{text-align:center;text-decoration:none;transition:.3s;}.lgm_blog_drop_shadow{-webkit-box-shadow:0px 0px 10px 0px rgba(0,0,0,.25);box-shadow:0px 0px 10px 0px rgba(0,0,0,.25);}.lgm_blog_top_border{border-color:#a1007d;border-top:solid;border-width:6px;}.uc_post_title a{font-size:16px;font-weight:700;text-decoration:none !important;margin-bottom:20px;}.uc_post_title a:hover{color:#24889c !important;}.uc_post_text{}.uc_post_date{font-size:14px;font-weight:600;margin-bottom:20px;}#uc_LGM_post_grid_elementor_28365747 .ue_post_grid_item{display:flex;flex-direction:column;}#uc_LGM_post_grid_elementor_28365747.uc_post_grid_style_one .uc_content{flex-grow:1;}#uc_LGM_post_grid_elementor_28365747.uc_post_grid_style_one .uc_content > div{height:100%;display:flex;flex-direction:column;}#uc_LGM_post_grid_elementor_28365747 .uc_post_button{margin-top:20px;}@media (max-width:1023px){#uc_LGM_post_grid_elementor_28365747.uc_post_grid_style_one .uc_post_grid_style_one_wrap{grid-template-columns:repeat(2,1fr);}}@media (max-width:639px){#uc_LGM_post_grid_elementor_28365747.uc_post_grid_style_one .uc_post_grid_style_one_wrap{grid-template-columns:repeat(1,1fr);}}#uc_lgm_archive_pagination_elementor_33a4be0{}#uc_lgm_archive_pagination_elementor_33a4be0 nav{padding:0px;margin:0px;}#uc_lgm_archive_pagination_elementor_33a4be0{display:flex;justify-content:center;}#uc_lgm_archive_pagination_elementor_33a4be0 .nav-links{display:flex;justify-content:center;}#uc_lgm_archive_pagination_elementor_33a4be0 .nav-links > *{}#uc_lgm_archive_pagination_elementor_33a4be0 .page-numbers{display:flex;align-items:center;justify-content:center;min-width:40px;height:40px;transition:.3s;text-decoration:none;}#uc_lgm_archive_pagination_elementor_33a4be0 a.page-numbers,#uc_lgm_archive_pagination_elementor_33a4be0 .dots{color:#24889c;background-color:rgba(255,255,255,0);}#uc_lgm_archive_pagination_elementor_33a4be0 a.page-numbers:hover{color:#36b0c9;background-color:rgba(255,255,255,0);}#uc_lgm_archive_pagination_elementor_33a4be0 .page-numbers.current{background-color:#36b0c9;color:#fff;}#uc_lgm_archive_pagination_elementor_33a4be0 .page-numbers.prev,#uc_lgm_archive_pagination_elementor_33a4be0 .page-numbers.next{padding-left:15px;padding-right:15px;}#uc_lgm_archive_pagination_elementor_33a4be0 .prev:before{font-family:"Font Awesome 5 Free";content:"";display:inline-block;vertical-align:middle;font-weight:900;padding-right:10px;}#uc_lgm_archive_pagination_elementor_33a4be0 .next:after{font-family:"Font Awesome 5 Free";content:"";display:inline-block;vertical-align:middle;font-weight:900;padding-left:10px;}