Regulatory Submission Software
Regulatory submission software takes the guesswork out of Structured Product Labeling (SPL)/Structured Product Monograph (SPM) submissions by giving you real-time validations. SPL Portal by Intagras is the all-in-one solution you need to ensure your regulatory submissions are compliant and complete.
What Are Regulatory Submissions?
To bring its products to market, a pharmaceutical company’s regulatory documentation must be submitted and approved by that market’s regulatory authority. Regulatory submissions include product registrations, facility registrations and any associated documents.
What is Regulatory Submission Software?
Companies utilize regulatory submission software to ensure the regulatory compliance of FDA and Health Canada submissions. The FDA and Health Canada are regulatory authorities that require regulatory submissions to be made in a specific Structured Product Labeling (SPL) (in the U.S.) or Structured Product Monograph (SPM) format (in Canada), which are updated regularly.
Without regulatory submission software, you must navigate the confusing maze of regulatory submissions on your own. SPL Portal is the regulatory industry’s first and leading SaaS solution for SPL/SPM creation and management. SPL Portal users also get access to our team of experts who interact with the FDA every day.
Where Do Regulatory Submissions Go?
In the United States, Structured Product Label (SPL) submissions are sent to the FDA. Structured Product Monograph (SPM) submissions go to Health Canada.
Within the FDA are three centers for product label submissions: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM). CBER protects public health by making sure biological products are safe and effective, while CDER and CVM ensure the safety of over-the-counter and prescription drugs for humans and animals, respectively.
Pharmaceutical companies can easily navigate FDA submissions through the SPL Portal, which serves as one XML repository for your product labeling.
Health Canada Submissions
SPL Portal Supports SPM and 7 Types of FDA SPL Files
1. Drug Listing (FDA)
Drug establishments are required to provide the FDA with a current listing of all drugs/products manufactured, prepared, propagated, compounded or processed for sale in the United States at their facilities. Product Registrations/Listings SPL submissions are used to register/list those products with the FDA, as well as to register/list National Drug Codes (NDCs) with the FDA.
The product registration/listing information includes the product’s Labeler, Facility/Manufacturer information, key product details such as Active and Inactive Ingredients, Application Numbers, packaging configurations, and Content of Labeling.
For most drug products, the information provided in these SPL files is ultimately included in the National Library of Medicine DailyMed repository, which is publicly available via their website.
2. Establishment Registration
All U.S. drug manufacturers are required to be registered by the FDA. Before an establishment can be registered, it must have been assigned a DUNS number by Dun & Bradstreet.
Additionally, the registration file contains addresses and contact information, importer and U.S. Agent information for foreign establishments and the establishment’s business operations. A registrant can register multiple establishments within a single SPL file, but each establishment may only be listed in one registration.
Establishments must be registered within 5 days of beginning operations. Additionally, establishments must renew their registration annually between October 1 and December 31 of each year.
3. NDC Labeler Code Request
4. Lot Distribution Report
5. Wholesale Drug Distributor/Third Party Labeler (WDD/3PL) Registration
6. GDUFA Self-Identification
7. Blanket No Change Certification
When Are WDD/3PL Submissions Due?
When Are GDUFA Submissions Due?
When Are BNCC Submissions Due?
Why Choose Intagras for your SPL/SPM Needs?
SPL Portal is the leading solution for SPL and SPM submissions. Converting Word files into SPLs can be challenging when you don’t know the idiosyncrasies. SPL Portal makes it possible to manage SPL submissions easily because it validates your files within the system. This means you don’t need to know how to code or keep up with current FDA guidance. SPL Portal handles all the details for you.
Need regulatory submission help? Talk to us.
Have questions? Need more info? Talk to one of our experts or request a demo of our SPL Portal today.