fda consulting group llc - splgenie - 11-3-16

14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323

FDA CONSULTING GROUP

THE CLOUD SOLUTION TO YOUR FDA ELECTRONIC REGISTRATION ISSUES

14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC

FDA Registrations Don’t Come with Instruction Electronic registration of your establishment and products can be intimidating. That’s why we have developed SPL Genie™, a proprietary Cloud Application that makes the process human, without any knowledge of SPL, HL7 or XML. Try the best solution in the industry.


What we do◦ Establishment Registration◦ Drug Listing and Delisting◦ FEI Request and Registration◦ Labeler Code Request and Activation◦ Product Registration

◦ Manufactured◦ Repackaged◦ Labeled


FDA Consulting Group, LLC

The ProcessBE COMPLIANT!We make the process simple, easy, and headache-free



FDA Establishment RegistrationElectronic Submission21 CFR PART 207 510 AND 351


What is it? Section 510(p) of the Act 21 CFR 207.40, as amended by the FDA, now requires that drug establishment registrations must be submitted electronically. Therefore, registration information should now be submitted electronically using SPL files with coded data fields.


What can happen? Failure to register in accordance with section 510 of the Act is a prohibited act under section 301(p) of the Act. Also, under section 502(o) of the Act, a drug is misbranded if it is manufactured in an establishment in any State not duly registered under section 510 of the Act.


We can turn days of frustration into minutes of work.


How can we help? We have the expertise and proprietary software designed specifically to register both establishments and drugs with the FDA.

You can quickly and easily register online at fdaconsultinggroup.com. Once registered you can solicit a new Labeler Code (NDC), request or add your Facility Establishment Identifier (FEI) to your Drug Establishment Registration or List/Edit/Remove Product Listings.

http://www.fdaconsultinggroup.com/


How can we help? As easy as filling out our registration form. You will need to have the following information available to register:◦ DUNS Number◦ Company Name and Address◦ Contact Name and Email◦ Facility Operation



FDA Drug ListingElectronic Submission21 CFR PART 207 510 AND 351


Who must list, when, and how? Registrants not exempt under 21 CFR 207.10 must submit the initial listing information for all drugs in commercial distribution at the time of their initial registration of their establishment(s).


What can happen? Failure to provide any listing information required by section 510(j) of the Act is a prohibited act under section 301(p). Also, under section 502(o) of the Act, a drug is misbranded if it was not included in a list required by section 510(j) of the Act.


How can we help? Fill out the registration form and we will take it from there to the point of compliance. No need to worry about electronic gateways, error on submissions, or secure communication problems. From Establishment Registration to Product Listing/Delisting we will take it from your busy time and make it a back office task that will be done right the first time.


What is needed?◦ Name of establishment(s) manufacturing or processing the listed drug and the type of operation(s) performed

◦ DEA schedule◦ Route(s) of administration◦ Inactive ingredients◦ Marketing information (e.g., category, start/stop date)◦ Information related to the application (e.g., type and year of approval) or OTC monograph citation number

◦ Package size and type◦ Label Image



Facility Establishment Identifier


What is it? An FDA Establishment Identification (FEI) number is a unique identifier issued by the FDA to track inspections of the regulated establishment or facility. An FEI is part of the required information to meet self-identification in the Generic Drug User Fee Amendments of 2012 (GDUFA.)


How can we help? Adding the Facility Establishment Identifier (FEI), after registration is completed, is a simple process to complete with our cloud application.



Labeler Code / NDC


Labeler Code (NDC) The NDC labeler code is a unique ten-digit, three-segment number which serves as a product identifier for human drugs. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.


Labeler Code (NDC) First segment of NDC Labeler code identifies the establishment. The FDA will assign this number and will be unique for each establishment (manufacturer, packer, labeler etc...).

Second segment of NDC Labeler code identifies the drug (strength, dosage and formulation).

Third segment of NDC Labeler code identifies the package size and package type.


Need a Labeler Code (NDC)? Our cloud application makes requesting one as easy as pressing the submit button. Once received we will activate and you are then ready to list products.



Product Registration


Product Registration Anyone who has spent time trying (and often failing) to get their products listed with the FDA, knows how daunting it can be. We offer a simple solution for Manufacturers, Repackagers, Relabelers and Pharmacies. As a Repackager/Relabeler your options include Zero Data Entry Listing™


SPL Genie™ Our proprietary Cloud application makes FDA facility and product registration simple from your computer or mobile device.◦ Web App

◦ http://splgenie.com/demo.aspx ◦ Mobile App

http://splgenie.com/demo.aspx


Web Solution


Create an Account


Enter and Manage Products


Download SPL File for FDA Submission


Mobile Apps Simple Steps Screen Shots


What do our clients think? “We have found FDA Consulting’s Drug Product Listing solution to be fast and accurate. Their team is both highly innovative and responsive. I believe it to be the best solution in the industry.”

Walter Hoff, CEO, A-S Medication Solutions

“We have utilized FDA Consulting Group to maintain our compliance standards related to the listing of repackaged NDC numbers with the FDA. Their process is simple, accurate and effective. We are very happy with the decision to outsource this aspect of our business to create internal efficiencies as well as to maintain our compliance with the ever changing regulatory agencies.”

Scott Harkins, Managing Director, Unit Dose Services, LLC


Summary We have the expertise and proprietary software designed specifically to register both your establishment and your drugs with the FDA.Contact us at 855-FDA-REGS. We’ll help you ensure compliance with the FDA Regulations.


Fee Schedule Programs

◦ Monthly

◦ A la carte


The best solution in the industry

fda consulting group llc - splgenie - 11-3-16

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