DRUG SERVICES FOR THE UNITED STATES
We offer a full service to guide your company through the FDA drug approval process. All establishments that are involved in the production, development, packing or storage of products that are classed as drugs in the U.S. are required to register with the FDA. Cosmereg provides assistance for NDA, ANDA, Establishment registration, OTC drug product listing, NDC number, SPL authoring , self-identification GMP compliance.The same applies for any drug products for import to the U.S. We can help you to identify whether you need to register your establishment with the FDA and guide you through the process if necessary
- Accurate label review
- Fast turnaround
- 10 years of experience
U.S. FDA DRUG REGULATIONS
Register your establishment with FDA & Renewal Process
The first step in ensuring that your product can be sold in the U.S. is to register your business with the FDA. Cosmereg can assist you with this process, to ensure that your business and your products fulfill the United States FDA Registration Requirements.
NEW DRUG APPLICATION
Any foreign business wishing to market their products in the US must do so via a designated US Agent. Cosmereg offers a full US Agent service to our foreign clients. We can assist you in filing New Drug Applications (NDAs) and scheduling meetings with the FDA. We can act as an intermediary to help you to resolve any disputes. We can also follow up on applications and registration processes, to ensure that all the necessary paperwork is completed as quickly and conveniently as possible.
GENERIC DRUG APPLICATION
The submission process for approval for a Generic Drug is slightly different to a New Drug. An Abbreviated New Drug Application (ANDA) must be submitted. This process is often much quicker than the NDA process. Cosmereg can help your business save time and money with our drug application support services.
DRUG LISTING & NATIONAL DRUGS CODE SERVICES
All companies that wish to market drugs in the US must register their manufacturing facilities and provide full information about all the drugs that they wish to distribute commercially. Cosmereg can assist you throughout the entire process of establishment registration. We can also help you to apply for product listing and the National Drugs Code assignment.
DRUG LABELLING SERVICES
The FDA has strict requirement for drugs labelling and health claim substantiation. Any labelling information submitted electronically must be completed in accordance with the Structured Product Labelling (SPL) standard, based on extensible markup (XML) language. Cosmereg can help your business to ensure that labelling applications meet strict FDA guidelines. Cosmereg can also provide templates to help your submission to meet the SPL standard, along with a document detailing FDA regulations and the SPL standard guidelines in full.
NO CHANGES CERTIFICATION OF PRODUCT LISTING
The FDA requires all drug listings to be updated annually. If no changes have been made to the product, you can submit a blanket ‘no changes certification’. Cosmereg can help you to get ‘no changes certification’ for your listed products in only two days. Failure to submit ‘no changes certification’ will result in your products being removed from NDC directory and you will no longer have the right to market these products in the US.
ELECTRONIC COMMON TECHNICAL DOCUMENT SERVICES ECTD
As of May 2018, most submissions to the FDA must be made via Electronic Common Technical Document (eCTD) filing. Here at Cosmereg, we offer a complete solution for eCTD publishing services. We can help your business to get to grips with the new, online service. We can also reduce the overheads associated with converting your documents into eCTD format.
FDA DRUG MASTER FILE DMF
A Drug Master File (DMF) is a document that is submitted to the FDA which includes a large amount of potentially confidential information about where, how and why human drugs are produced and stored. As of May 2018, all DMFs except Type III DMFs must be submitted in eCTD format. Cosmereg can support you through this process. As of May 2020, Type III DMFs must also be submitted in this format. Cosmereg can help you to get all your paperwork in order, ready for this change.
US AGENT SERVICE
Foreign manufacturers who wish to sell their Drug Products on the U.S. market must register with the FDA via a US FDA Agent. These agents act as an intermediary between the FDA and the manufacturer and are the first point of contact for the FDA. Cosmereg can provide a U.S Agent service to any clients wishing to expand their business to the U.S. market.
ADVERSE EVENT REPORTING
It is the responsibility of the FDA to protect U.S. citizens from unsafe products. It is the responsibility of the manufacturer to inform the FDA of any adverse events that could potentially be associated with their products. Cosmoreg can help your business to locate and complete the necessary documentation on the Safety Reporting Portal, as stipulated in section 761 of the Federal Food, Drug and Cosmetics Act.
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FAQ
ANDA is the process for FDA approval for generic drugs. ANDA stands for ‘Abbreviated New Drug Application’.
As long as all of the information that you have submitted is complete and correct, your ANDA application should be approved within 16 months. Incorrect submissions can lead to delays. Contact Cosmereg today if you have any questions about ANDA applications.
All establishments must renew their registration annually, no earlier than October 1st and no later than December 31st each year.
eCTD stands for ‘Electronic Common Technical Document’. As of May 2018, most applications to the FDA must be submitted in this format. Digital submissions mean that agencies can easily track the progress of submissions. Applicants can also update their files more easily in this new, digital format.
DMF stands for ‘Drug Master File’. This is a document that contains a large amount of detailed information about the formulation, manufacture, packaging and storage of drugs to be evaluated by the FDA.
The Labeler Code is a unique number that the FDA assigns to the producer/labeler of a drug product.
NDC stands for National Drugs Code. This is a ten digit code that is used as a unique identifier for each drug listed by the FDA. The first five digits of the code are the same as the labeler code. Before requesting an NDC code, you must first obtain a labeler code for your product.
