Compliance solutions

for the drug industry.

Bring safe products to market with our professional, affordable services tailored to U.S. and international drug establishments.

Drug Industry Services

We’ve been helping drug companies navigate compliance for over 20 years. From establishment registration and drug product listings to detention assistance, we focus on compliance so you can focus on your business.

FDA Registration and Listings

Promote consumer safety by completing your FDA registration correctly with Registrar Corp. We offer annual FDA Establishment Registration and commercial drug listing support, DUNS number assistance, and U.S. Agent representation.

Drug Master Files

Share your proprietary product information securely. Registrar Corp works with you to prepare Drug Master Files (DMFs) in electronic common technical document (eCTD) format. We can also submit them for you to 18 regulatory bodies worldwide, including FDA, and the National Medical Products Association (NMPA) in China.

Label and Ingredient Reviews

Comply with strict drug labeling requirements by working with a professional team. Our regulatory specialists work closely with you to review product labeling, assets, ingredients, and more. We also offer in-depth reports of our findings along with details of current regulations to make compliance easier.

Import Alerts

Address Import Alerts and Detentions without Physical Examination (DWPEs) effectively and efficiently. We offer professional support with developing a corrective plan of action, documenting compliance across shipments, and submitting complete and accurate petitions for removal.

Detention Assistance

If your shipment has been detained by FDA for potential noncompliance, we can help. Registrar Corp’s professional team will assist you to submit a Testimony of Admissibility or reconditioning proposal and address noncompliance issues.

Other Services

Stay on top of all FDA drug regulations. Registrar Corp offers the following additional regulatory services for drug companies:

  • Third-Party Logistics (3PL) provider and Wholesale Drug Distributor (WDD) annual reporting
  • Registrant Contact support for Registration and Product Reporting for Outsourcing Facilities
  • Adverse Event contact forwarding
  • Annual self-identification submission for generic drug and pharmaceutical companies
  • Remitting user fees under GDUFA and OMUFA fee programs
  • Annual Amount Reporting under CARES for listed Drug and certain Biologic products
  • Maintance for approved NDA / ANDA drug applications
  • Labeler Code Request and Listings for Private Label Distributors (PLDs)

Helping you achieve better drug compliance.

Stay compliant and bring your drugs and drug products to market safely with Registrar Corp.

Frequently Asked Questions

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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