US Agent – FDA Support

HOW TO FILE A DMF

DMF (Drug Master File) is a confidential & detailed submission to FDA.

There are several steps involved in filing a DMF with the US FDA:

1. Determine the Type of DMF

Identify the type of DMF you need to file (Type II, III, IV, or V).

2. Prepare the DMF Document

Cover Letter: Include a cover letter containing the type of DMF, the specific content included, and contact information.
Administrative Information: Provide the DMF holder’s and US Agent’s contact details.
Technical Content: This varies depending on the type of DMF. It includes manufacturing processes, specifications, testing methods, stability data, and other technical details.
References and Appendices: Include all relevant references, supporting documents, and appendices.

3. Format of Document

The DMF must be prepared according to the FDA guidelines on electronic submissions using the eCTD format.

4. Compile the Submission

Ensure all sections are complete and properly formatted.
Compile the document into eCTD format.

5. Obtain a Pre-Assigned Number

Request a pre-assigned application number for DMF from the FDA.

6. Submit the DMF

Submit the DMF electronically via the FDA’s ESG portal.

7. Pay the Fee

Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. There is no FDA fee for other types of DMF submissions.

8. Acknowledge Receipt

Once submitted, FDA will acknowledge receipt of the DMF.

9. Annual Updates and DMF amendments

Submit annual updates and amendments as needed.
Keep the FDA informed of any changes to the DMF’s content or contact information.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

A Drug Master File (DMF) is a confidential and detailed document submitted to the US FDA by a drug manufacturer. It contains comprehensive information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF submission is not required by FDA regulation. DMF is solely submitted at the discretion of the DMF holder. A MDF is not approved or disapproved. Technical contents of a DMF may be reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. DMF allows FDA to review this information to ensure the quality and safety of the drug products without disclosing proprietary information to the drug product’s sponsor.

The submission of a DMF can be made by:

API manufacturers
Excipient manufacturers:
Container Closure System manufacturers
Drug Product manufacturers

Types of DMF:

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (discontinued since September 2010).
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product.
Type III: Packaging Material.
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation.
Type V: FDA Accepted Reference Information

Non-US DMF applicants are required to appoint a US Agent in their DMF for FDA communication purpose.

Liberty Management Group Ltd. can help you DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

What information is required in the FDA registration of a food facility?

As per 21 CFR 1.232, the following information is required for US and non-US food facility registrations:

Facility name, address, phone number and email address
DUNS number
Preferred mailing address, phone number & email address, if different from facility
Parent company name, address, phone number & email address (if the facility is a subsidiary of the parent company)
Facility Emergency contact name, phone number & email address
All alternate names the facility uses
US Agent name, address, phone number & email address
Name, address, phone number & email address of the owner, operator, or agent in charge
Applicable food product categories of any food manufactured, processed, packed, or stored at the facility
The types of activity at the facility for each food product category
A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, phone number & email address, the individual who authorized submission of the registration.

Liberty Management Group Ltd. can help you with FDA registration & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Drug Master File

A Drug Master File or (DMF) is a confidential submission to the US FDA that provides detailed information about facilities, processes, or components used in the manufacturing, processing, packaging, and storing of drugs.

The DMF is submitted by a manufacturer, supplier, or developer of an API (active pharmaceutical ingredient), excipient, or packaging material, and it allows them to provide information to the regulatory authority without disclosing the information to their customers or competitors.

A DMF is referenced in a drug application, such as an ANDA or NDA Application, by the applicant who intends to use the information contained in the DMF to support their own application. The regulatory authority can then review the information in the DMF as part of the evaluation of the drug application.

The purpose of a DMF is to provide information to the regulatory authority, without disclosing proprietary information to the public, to support the regulatory review process of a drug product. This allows the regulatory authority to evaluate the quality, safety, and efficacy of the drug product without needing to disclose confidential information to third parties.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. DMFs are subject to strict confidentiality requirements and are not publicly available.

DMF holders are required to notify FDA of any changes in the contents of DMF, authorized parties, transfer of ownership etc. An annual report must be submitted every year listing all changes since the previous annual report. Foreign DMF holders are required to appoint a US Agent in their submissions.

Types of Drug Master Files:

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF original and annual report submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

What does a US Agent do?

A US FDA Agent acts as a domestic representative for foreign establishments that are engaged in the manufacturing, processing, packaging, or holding of FDA regulated products, such as food, drugs, medical devices &, cosmetics.

The role of the US Agent is primarily to serve as a point of contact between the FDA and the foreign establishment.

Key responsibilities of a US Agent may include:

Assisting FDA to communicate with foreign establishment including responding to inquiries, submitting required documentation, and facilitating inspections.
Serving as a liaison for regulatory compliance matters, including ensuring that the foreign establishment meets FDA regulatory requirements for the products they are dealing in.
Facilitating the submission of required registrations, listings, and other regulatory submissions to the FDA.
Coordinating with the FDA in the event of product recalls, adverse events, or other safety issues related to products manufactured or distributed by the foreign establishment.
Keeping the FDA updated of any changes that are relevant to the foreign establishment’s operations, such as changes in ownership, new manufacturing processes, or product formulations.

The US Agent plays a critical role in helping foreign establishments navigate the regulatory requirements of the FDA and ensuring compliance with US laws and regulations governing the safety and quality of FDA regulated products.

Liberty Management Group Ltd. can be your US Agent and help with registration & other FDA requirements.

Namrata

Regulatory Consultant

support@libertymanagement.ushttp://www.fdahelp.us

Drug Master File (DMF)

A Drug Master File (DMF) is a confidential submission to FDA to provide detailed information about the facilities, processes or articles used to manufacture, process, package or store human drugs.

DMF submissions are not mandatory and DMF applications are neither approved nor rejected by FDA. It is submitted by a drug manufacturer to provide confidential information about the drug’s quality, safety, and efficacy. The information submitted in a DMF is usually referenced only during the IND, NDA, ANDA or export application. A DMF contains technical information about a drug, including its chemical and physical properties, manufacturing processes, and analytical methods.

DMFs are often submitted by drug manufacturers to support the approval of their drug products. DMFs are subject to strict confidentiality requirements and are not publicly available.

Types of Drug Master Files

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

Liberty Management Group Ltd. can help you with DMF submissions & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us

RESPONSIBILITIES OF A US AGENT

All foreign food facilities that engage in manufacture, pack or holding of food for human or animal consumption in US are required to register with FDA and identify a US Agent on their registration.

All foreign drug establishments that manufacture, repack, or re-label drug products and import or offer for import drug products to the US must register with the FDA and identify a US Agent on their registration.

All foreign medical device establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the US must identify a US Agent on their FDA registration.

The responsibilities of a US Agent include:

Assisting FDA in communications with the foreign establishment,
Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the US.
Assisting FDA in scheduling inspections of the foreign establishment
If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US Agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Each foreign establishment must appoint only one US Agent. The foreign establishment must provide the name, address, telephone number, fax number, and e-mail address of the US Agent.

The US Agent will need to accept such appointment timely. The US Agent must reside or maintain a place of business in US. They must be available to answer the phone during normal business hours.

Liberty Management Group Ltd. can assist you with FDA registration & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Who needs to register with FDA?

Owners, operators or agent in-charge of domestic as well as foreign facilities that are engaged in manufacturing, processing, packing or holding for human or animal foods for consumption in USA are required to register with FDA unless exempt from the requirement to register under 21 CFR 1.226.

Facilities that are exempt are:

Farms
Restaurants
Retail Food Establishments e.g. grocery stores
Nonprofit Food Establishments
Fishing Vessels
Facilities that manufacture/process, pack, or hold food entering US solely for the purpose of exportation or trans-shipment to another country
Private residence of individuals
Post Offices, Freight Forwarders

While registering a facility with FDA, the owner, operator or agent in-charge is required to provide accurate Facility info including the names of Emergency contact, Products, Trade names under which it conducts business and US Agent for the purpose of FDA communications. Also, owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

If a facility is required to register with FDA, they must register before beginning manufacturing, processing, packing, or holding operations in USA.

In addition to registration, all registered facilities are also required to renew FDA registration between Oct -Dec every even numbered year. FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. Such registration will be cancelled and removed by FDA from its system.

Staring Oct 2020, FDA will mandate submission of UFI (Unique Facility Identifier) for all food facilities. This UFI will be required for all new registrations as well as registration renewals. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility’s UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

Liberty Management Group Ltd provides assistance with FDA Registration, Biennial Renewals, US Agent service and many other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: June 06, 2019

What are Food Additives?

Food Additives are substances the intended use of which results or may be expected to result, directly or indirectly, in its becoming a component of any food.

Direct Food Additives are any substances that are intentionally added to food to enhance or preserve its taste, texture, nutrition or appearance.

FDA registration is required for all domestic and foreign facilities that manufacturer, pack, label and store food additives. In addition all foreign facilities must also designate a US Agent for the purpose of FDA registration.

All food additives are deemed unsafe and are subject to premarket approval by FDA unless the substance is GRAS (Generally Recognized As Safe).

It is the responsibility of the food manufacturers to make sure that all ingredients in his products are approved and are used within the permissible limits of law. The regulatory status of a food is affected by the regulatory status of each food ingredient. The authorization is determined by the identity, properties and limitations of use. The regulatory status may be checked at the FDA website.

Food additives can be of various kinds such as; pH Control Agents, Anti-caking Agents, Emulsifiers, Humectants, Stabilizers, Thickeners and Gelling Agents, Leavening Agents etc.

To market a new food additive or before using an additive already approved for one use in another manner that is not yet approved, a manufacturer or other sponsor must either submit a Food Additive Petition or submit GRAS notification.

A Food Additive Petition is either approved or denied by FDA. If an additive is approved, FDA issues regulations that may include the types of foods in which it can be used, the maximum amounts that can be used, and how it should be appear on food labels.

Alternatively, a manufacturer may choose to go with GRAS notification. Under GRASN, a company notifies FDA that a particular use of a substance has been determined to be GRAS and provide the same type and quality of data to the agency as in the FAP process. FDA reviews the notification data but there is neither approval not denial.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with FDA registrations, Label Review and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 14, 2019

FDA LACF Registration

All food facilities engaged in manufacturing, packing, labeling or holding of food for consumption in US must be FDA registered. In addition all foreign facilities must designate a US Agent for the purpose of FDA communications.

In addition, all commercial processors of low-acid and acidified foods located in the US and all foreign processors who export low-acid canned food (LACF) or acidified food products into the US must also register their processing plants (Food Canning Establishment Registration – FCE) and submit scheduled process filing with FDA.

LACF is any food with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85 excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.

An acidified food is a low-acid food to which acids are added and which has a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85.

Any LACF food offered for import that is manufactured in a facility with no FCE registration will be refused admission into US. Wholesalers, distributors, broker and importers are not required to register or file processes. But they must ensure that their suppliers FCE registration is in order.

Any manufacturer that is required to register as an FCE must also submit its scheduled process for all of its Low Acid Canned foods to FDA to obtain a SID number for all such products. The manufacturer’s scheduled process must be reviewed and accepted by FDA before any such food is permitted to enter the US. The manufacturer must update the SID filing if there is any change in the manufacturing process, container type, size etc.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Food Facility Registration, Food Canning Establishment Registration, Scheduled process filing and Label Review.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019