FDA registration made easy

FDA CONSULTING GROUP
THE CLOUD SOLUTION TO YOUR FDA
ELECTRONIC REGISTRATION ISSUES
14201 WEST SUNRISE BLVD, SUITE 106, SUNRISE, FLORIDA 33323

FDA 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 Process
BE COMPLIANT!
We make the process simple, easy, and
headache-free

FDA Establishment Registration
Electronic Submission
21 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.

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 Listing
Electronic Submission
21 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

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 registration made easy

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