Sungo

Home

> Industry

> Drug

> Drug Export to the U.S.

Service Schemes

Quotation Scheme

Service Schemes for Drug Export to the U.S.

If you are a drug manufacturer, and you want to enter the U.S. market, we provide you with the following service schemes:

1. FDA OTC registration (including drug establishment registration and listing of another type of OTC drug)

2. FDA NDC registration (FDA establishment registration/assisting in the submission of drug listing and label and updating of NDC and listing information)

· Labeling and ingredient inspection

· U.S. agent service

· Transfer of the old submission to the new FDA electronic system

3. FDA OTC pre-audit

4. FDA OTC factory inspection

OTC registration with FDA

OTC (over the counter) drugs must be safe and effective, and meet supervision requirements of the FDA and conditions of relevant monographs.

SUNGO’s experts help you correctly register your products as required by the FDA.

1. Registration

-Drug establishment registration

-Drug listing information

-List another type of OTC drug

-Update the registration information

2. Labeling and ingredient inspection

-Design and inspection of ingredient declaration

-Design and inspection of label declaration

-Design and inspection of package declaration

3. U.S. agent service

The U.S. FDA and Customs (and most of other importing countries) require the local or foreign manufacturers and distributors engaged in import and export to authorize a local agency. The said agency shall be responsible for the FDA/NDC and customs declaration and solve the regulatory problems of their products. SUNGO provides professional legal representation service for the customers. As your U.S. agency, we’ll try our best to provide all legal and scientific assistances needed for the U.S. market access.

NDC registration with FDA

NDC registration with FDA, SPL, ESG, DUNS, and DRLS

1. Registration

-FDA establishment registration

-Assist in the submission of drug listing and label

-Update NDC and listing information

2. Labeling and ingredient inspection

-Design and inspection of ingredient declaration

-Design and inspection of label declaration

-Design and inspection of package declaration

3. Registration certificate

4. U.S. legal agency

5. Transfer of the old submission to the new FDA electronic system

The submission of the drug establishment registration and drug listing information has changed from the original written form to the electronic form. If it is not a special case, FDA will not accept the written submission of this information. SUNGO can assist you to transfer your drug establishment registration and drug listing information to the new electronic system.

FDA OTC drug label audit and rectification services

FDA OTC drug label requirements

The FDA does not approve labels for OTC drugs sold under the OTC monograph, but the FDA regulates all OTC drug labels, such as direct container, outer package, and drug instructions. The required information includes the drug fact label and the principle display panel label. This regulation helps regulate the content and form of OTC drug labels. The registrant may upload the OTC drug label in an SPL file format at the time the drug is marketed.

Process and cycle of FDA label audit

1. Appoint a consultant to review the information of drug labels and packages currently in use as submitted by the enterprise;

2. After the audit, we will submit:

· A detailed report (30-40 pages in general) after our regulatory expert team’s audit to all elements of the label (including inner package, outer package and website).

· A modified electronic drawing which can be printed directly.

3. If the same label is changed within 45 days, we will provide a new report and audit for free.

Usually the handling cycle is 15 working days.

FDA OTC factory inspection counseling

According to the U.S. FDA regulations, random inspection will be conducted to establishments registered with the FDA. The basis of factory inspection includes 21 CFR, and FDA’s quality system guide and inspection guideline for drug establishments.

FDA inspection standards: FDA GMP CFR 210 & CFR 2ll factory inspection

FDA factory inspection is mainly divided into the following 3 types:

I. Pre-approval Inspection, i.e., “FDA factory inspection”: inspection for the production of new drugs and generic drugs;

II. Regular inspection: regular compliance inspection for approved drugs, biennial inspection in general.

III. Temporary inspection or supervision based on complaints, recalls or adverse reactions.

Timing of FDA factory inspection counseling

Generally, the U.S. FDA will notify the enterprise about 2 months before the date of the audit. We suggest that the enterprise get in touch with us as soon as it receives the notice, because the overall preparation time is very short. Of course, we encourage the enterprises that have already exported their cosmetics to the U.S. but have not yet received the audit notice from the U.S. to seek our counseling, so as to get prepared.

Service process and cycle

1. Analyze the gap between the existing QMS and regulatory requirements;

2. Consult the overall design of the process, including the site correction and the correction of documentation system and application;

3. Collect the existing documents: quality manuals, procedure documents, working instructions, process documents, inspection procedures, records, etc.

4. Review the document records and check the GMP of the whole production process and the GMP of the equipment and facilities maintenance based on the FDA audit requirements; the consultant and the relevant personnel of the enterprise correct the documentation system jointly;

5. Identify and correct the defects of workshops and warehouses;

6. Provide the audit skill training for relevant personnel of the enterprise;

7. Our auditor will conduct a simulated audit on the effectiveness of the system before the FDA audit;

8. Accompany the FDA auditor and be responsible for translation and communication in the factory inspection.

Cycle: it usually takes 2 months from receiving the notice to FDA completing the audit.

Quotation Scheme for Drug Export to the U.S.

Quotation principles for FDA OTC registration

The FDA OTC registration fee is divided into establishment registration fee and product registration fee. The quotation principles are as follows:

1) In general, different enterprises are charged differently;

2) The quotation for product registration is based on the number of products.

Quotation principles for FDA NDC registration

The FDA NDC registration fee is divided into establishment registration fee and product registration fee. The quotation principles are as follows:

1) In general, different enterprises are charged differently;

2) The quotation for product registration is based on the number of products.

Quotation principles for FDA label audit

FDA label audit is an off-site audit service based on product labels. The quotation principles are as follows:

1) One charge for one category of product labels;

2) For different models of similar products of the enterprise, we suggest that the enterprise make modification by itself according to the template we provide.

Quotation principle for FDA factory inspection counseling

Most of the FDA factory inspection counseling work needs to be done on site, so our quotation is based on the number of person-days. The factors influencing the number of person-days include:

1) Enterprise scale;

2) Classes and batches of the products the enterprise exports to the U.S.;

3) Whether the enterprise has a management system basis;

4) Whether the enterprise has a record of violations regarding the export to the U.S.;

5) Whether inspection accompanying and translation services are required;

6) In addition to the number of person-days in our normal counseling scheme, are there additional person-days required, such as testing support.