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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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
What we do◦ Establishment Registration◦ Drug Listing and Delisting◦ FEI Request and Registration◦ Labeler Code Request and Activation◦ Product Registration
◦ Manufactured◦ Repackaged◦ Labeled
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
FDA Consulting Group, LLC
The ProcessBE COMPLIANT!We make the process simple, easy, and headache-free
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
FDA Consulting Group, LLC
FDA Establishment RegistrationElectronic Submission21 CFR PART 207 510 AND 351
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
We can turn days of frustration into minutes of work.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
FDA Consulting Group, LLC
FDA Drug ListingElectronic Submission21 CFR PART 207 510 AND 351
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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).
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
FDA Consulting Group, LLC
Facility Establishment Identifier
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.)
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
How can we help? Adding the Facility Establishment Identifier (FEI), after registration is completed, is a simple process to complete with our cloud application.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
FDA Consulting Group, LLC
Labeler Code / NDC
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
FDA Consulting Group, LLC
Product Registration
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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™
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Web Solution
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Create an Account
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Create an Account
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Create an Account
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Create an Account
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Enter and Manage Products
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
Download SPL File for FDA Submission
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
Mobile Apps Simple Steps Screen Shots
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
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
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, 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.
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323FDA CONSULTING GROUP, LLC
Fee Schedule Programs
◦ Monthly
◦ A la carte
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323
The best solution in the industry