CINXE.COM

Letter of Authorization (LOA) Request for Drug Master File

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id="store.links" data-role="content"> <!-- Account links --> </div> </div> </div> <ul class="top-right-menu"> <li class="top-search"><label class="fa fa-search top-search-label"></label></li> <li class="top-account"><label class="fa fa-user-circle top-account-label"></label></li> <li class="top-cart"><label class="fa fa-shopping-cart top-cart-label"></label></li> </ul> <!-- top.search --> <!-- top.search --> <div id="print-header-contact"> <p class="welcome-msg"> <span>Have a question? <strong>+(65) 6776 7754 </strong> or Email Us at <a href="mailto:info@stemcell.com">info@stemcell.com</a> </span> </p> </div> <div class="has-quote-popup-box hidden"> <div><a class="has-quote-pop-close"><i class="fa fa-close"></i>Cancel</a> <form id="hq_form" class="sc-form popup" action="https://www.stemcell.com/sapquote/cart/clear/"> <h2>Your cart has an existing quote</h2> <div class="message"></div> <div class="form-list-wrapper"> <p class="note"> Your shopping cart contains an active quote order and 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lc.async = true; lc.src = ('https:' === document.location.protocol ? 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Please click “Submit” after completing all required fields(*). STEMCELL will contact you once we have reviewed and processed your request. </p> <p>If you are located outside of the U.S., STEMCELL can work with you to provide Regulatory Support Files directly to your Regulatory Agency to support your submission. Please <a href="/contact-us">contact us here</a> or via your local representative.</p> </div> <form class="sc-form" id="form" action="/eloqua/submit" method="post" name="form"> <div class="section form-list-wrapper"> <!-- <p>Please fill out the form below</p> --> <div class="user-fields"> <div class="fields"> <div class="field"> <label>Application Number (i.e. IND, BLA, DMF)*</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="app_number" id="app_number" placeholder="" value=""/> </div> </div> <div class="field"> <label>Application Title *</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="app_title" id="app_title" placeholder="" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <label>FDA Division (i.e. CBER, CDER, CDRH)*</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="fda_div" id="fda_div" placeholder="" value=""/> </div> </div> <div class="field"> <label>Principal Investigator(s)*</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="pi" id="pi" placeholder="" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <label>Company/Sponsor Name *</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="sponsor" id="sponsor" placeholder="" value=""/> </div> </div> <div class="field"> <label>Brief Description of Study *</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="study" id="study" placeholder="" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <label>Disease Indication *</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="disease" id="disease" placeholder="" value=""/> </div> </div> <div class="field"> <label>Application Phase *</label> <div class="input-box"> <input type="text" class="input-text required-entry" name="phase" id="phase" placeholder="" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <label>STEMCELL Product in Use *</label> <div class="input-box"> <select name="product_used" id="product_used" class="required-entry" style="font-size: 14px; line-height: 16px; color: #53585A; padding: 3% 4%; width: 92%; height: auto; resize: none;"> <!--<option value="">Select</option>--> <option value="mtesr1">mTeSR&trade;1 (85850, 85857, 85870, 85875)</option> <option value="stemspan-aof">StemSpan™-AOF (100-0130)</option> <option value="gcdr">GCDR (100-0485, 100-1077)</option> <option value="relesr">ReLeSR (100-0483, 100-0484)</option> <option value="mtesr-plus">mTeSR™ Plus (100-0276)</option> <option value="tesr-aof">TeSR™-AOF (100-0401)</option> <option value="immunocult-xf-tcell">ImmunoCult™-XF T Cell Expansion Medium (10981)</option> <option value="immunocult-xf">ImmunoCult™-XF (100-0956)</option> <option value="immunocult-cd3-cd28">ImmunoCult™ Human CD3/CD28 T Cell Activator (100-0784)</option> <option value="immunocult-cd-cd28-cd2">ImmunoCult™ Human CD3/CD28/CD2 T Cell Activator (100-0785)</option> </select> </div> </div> <div class="field"> <label>Tentative FDA Application (IND, BLA, DMF) Submission Date *</label> <div class="input-box"> <input type="date" class="input-text required-entry" name="date" id="date" placeholder="" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <label>How did you hear about us? *</label> <div class="input-box"> <select name="referral" id="referral" class="required-entry" style="font-size: 14px; line-height: 16px; color: #53585A; padding: 3% 4%; width: 92%; height: auto; resize: none;"> <!--<option value="">Select</option>--> <option value="current">Current Customer</option> <option value="word_of_mouth">Word of Mouth</option> <option value="search">Internet Search</option> <option value="search">Other</option> </select> </div> </div> </div> <div class="clear"></div> </div> <label>This Request Form is completed by</label> <div class="user-fields"> <div class="fields"> <div class="field"> <div class="input-box"> <input type="text" class="input-text required-entry" name="first_name" id="first_name" placeholder="First Name *" value=""/> </div> </div> <div class="field"> <div class="input-box"> <input type="text" class="input-text required-entry" name="last_name" id="last_name" placeholder="Last Name *" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <div class="input-box"> <input type="text" class="input-text required-entry" name="email" id="email" placeholder="Email *" value=""/> </div> </div> <div class="field"> <div class="input-box"> <input type="text" class="input-text required-entry" name="company" id="company" placeholder="Company/Institution *" value=""/> </div> </div> </div> <div class="fields"> <div class="field"> <div class="input-box"> <input type="text" class="input-text required-entry" name="phone" id="phone" placeholder="Telephone 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