Drug compliance made quick and easy
U.S. FDA compliance leaves no room for error. Registrar Corp is the trusted partner helping drug manufacturers, distributors, API/excipient suppliers, and OTC brands maintain compliance and ensure smooth market entry post-approval.
Leading Drug Companies Trust Registrar Corp
With over 20 years of expertise, we’ve helped more than 3,000 + drug companies get FDA compliance right the first time with expert support.
Your Drug Product is Ready, But Can You Sell It?
Your drug may be cleared by the FDA, but if your compliance infrastructure isn’t, you’re not going anywhere. Behind every approved product lies a complex chain of filings, listings, and clearances that must be in sync before you can ship. One missed step, and you’re facing border holds, rejections, or costly delays. In today’s market, success isn’t just about getting approved—it’s about being truly launch-ready.
FDA Stringent Requirements Made Easy
Obtain a DUNS Number for facility registration. Make sure DUNS data is current if you have a number already.
Register your facility and keep information up to date.
Apply for a labeler code and list your products.
Appoint a U.S. Agent if your facility is based outside the U.S.
Complete GDUFA Self-Identification if required by generic drug requirements.
Pay GDUFA and OMUFA fees before due dates if applicable to you.
List all drug products with the FDA before marketing.
Reserve a National Drug Code (NDC) for new products.
Update or reactivate listings as formulations or details change.
Delist products that are no longer marketed.
Report drug amounts annually under the CARES Act.
Recertify listings every year to maintain compliance.
Ensure labels are accurate, balanced, and not misleading.
Submit labels in FDA’s Structured Product Labeling (SPL) format.
Follow the required Drug Facts panel format for OTC drugs.
Maintain consistency across all label components (PI, PIL, CDS, etc.).
Include required warnings and safety information.
Update labels promptly for safety changes.
Register your facility with FDA before importing.
Resolve import alerts and detentions promptly.
Ensure OTC drugs meet monograph standards.
Report annual distribution under the CARES Act.
Obtain state licenses for 3PL/WDD operations.
Submit Master Files in eCTD format as required by FDA and global agencies.
Keep files current with updates, amendments, and annual reports.
Ensure accurate Letters of Authorization (LOAs) are filed for referencing applications.
Close or transfer files properly to maintain regulatory alignment.
Securely store and track submissions with version control.
Respond to agency queries and deficiencies in a timely manner.
Align with formatting and technical standards for each agency (FDA, EMA, TGA, etc.).
Update existing Master Files to the eCTD 4.0 format.
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FAQs for FDA Drug Compliance
Domestic or foreign owners or operators of establishments that manufacture, prepare, propagate, compound, or process a drug or drugs and are not considered exempt must register their facility with FDA, according to the Code of Federal Regulations. In general, exemptions include pharmacies, professional licensed practitioners, researchers, teachers, analysts, and distributors.
Information you must submit as part of your FDA facility registration with your Structured Product Labeling (SPL) file includes:
- Company Name and full address of each establishment
- Name, address, phone number, and email address of official contact
- Type of operation(s) performed at each establishment
- DUNS number
- Facility Establishment Identifier (when assigned)
Non. U.S. establishments must also include:
- Name designated U.S. Agent
- Name of each importer known to the establishmentName of each agent, broker, or other entity, other than a carrier used to facilitate the import of their drug into the U.S.
- Include DUNS number, phone number and email address for each entry.
See Title 21 of the Code of Federal Regulations for a complete list.
All drug establishments that are not considered exempt and must register with FDA must also submit initial listing information for all drugs in commercial distribution at the time of their original FDA facility registration, according to the Code of Federal Regulations.
In general, exemptions include pharmacies, professional licensed practitioners, researchers, teachers, analysts, and distributors.
Information you must submit as part of your FDA drug listing includes:
- Name of establishment(s) manufacturing or processing the listed drug and the type of operation(s) performed
- DEA schedule
- Route(s) of administration
- Dosage Form
- Ingredients (active with strength amounts and inactive)
- 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
- NDC Product Code for a source drug repacked or relabeled
- Unique Ingredient Identifiers (UNII) and other code sets
- Distinctive Characteristics of certain listed drugs
- Labeling artwork
- National Drug Code (NDC) number
See the Code of Federal Regulations for more details.
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), or the National Medical Products Association (NMPA) in China.
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