Electronic Common Technical Document -eCTD eCTD is a harmonized regulatory filing format widely accepted by several countries. ICH adopted countries have common modules 2,3,4 and 5 and customized administrative module 1 according to country specific requirements. Contents of e-CTD ICH recommended CTD folder structure XML backbone containing metadata such as document id, document version, hyperlinks, … Continue reading eCTD Requirements and cost effective solutions
In order to market food products in the United States, you must first comply with the following requirements: Appoint a US Agent (for all foreign companies) Establishment Registration Labelling GMP manufacturing Prior import notice Please click here for detailed information. Pragmatic Compliance LLC can offer you all the guidance to help you market your food … Continue reading How can I market food products?
An FSVP Agent or FSVP importer is an individual or a company, residing or maintaining a business in the USA, who is the designated representative of a foreign supplier for FSVP compliance purpose. When is an FSVP Agent or FSVP Importer is required ? An FSVP Agent is required when there is no U.S. owner … Continue reading FSVP Agent (FSVP Importer)
When is the FDA Biennial Registration Renewal period for Food Facility ? Food facility registration must be renewed every even calendar year, between October and December. Example : If you have submitted initial registration in the month of September 2017, then you must renew food facility registration before December 2018 and your next renewal will … Continue reading FDA Biennial Registration Renewal period Food Facility
FSVP stands for Foreign Supplier Verification Program. As per the FDA’s FSMA rule foreign suppliers must conduct a supplier verification to make sure that the foreign supplier is complying with U.S. safety standards. A U.S importer is responsible for foreign supplier verification. Importers who are covered by the FSMA rule must have a foreign supplier … Continue reading What is FSVP ?
FDA requirements for food 1. Food Facility Registration Food facility registration is one of the FDA requirements for food products. If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility. Pragmatic Compliance LLC shall act as U.S … Continue reading What are the FDA requirements for food
No. There is no such provision in the regulatory framework to register each dietary supplement since it is not required by law. Food facility registration is the one of the FDA’s requirement as per Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
After you have provided the required information, it takes about 48 hours to complete the food facility registration.
Pragmatic offers complete solutions to comply with all the FDA requirements: US agent services, food facility registration, labelling review, and guidance for GMP compliance requirements. Please contact us for more information.
DMF fee is applicable only for type II DMFs (API or Drug Substance). There is no fee charged by FDA for packing material or excipient DMF. FY 2019 , DMF fee is $ 55,013. This fee should be paid well before referencing your DMF in your ANDA application. However, you can still submit the … Continue reading How much is the DMF Fee ?
The timeline for the DMF submission depends on the availability of technical documents. If you have all the documents – including Batch records, Specification, Method of analysis, In process specification, Raw material specification and testing reports, Impurity profiling, Batch analysis data, and stability study – it will take about 10 working days to compile the … Continue reading How much time is required for DMF submission?
Pragmatic offers a complete solution for all types of DMF submission to the FDA. We offer DMF review, compilation, technical gap analysis, eCTD conversion and submission through ESG. We also provide services for management throughout the lifecycle of a drug master file. Please contact us for more information.
A Drug Master File – or DMF – is FDA’s provision to submit confidentiality information on the chemistry, manufacturing and control information about a product for the agency’s evaluation.
How our company help you to meet self identification requirement ? FDAbasics can offer you complete support for self identification of your facility to comply with GDUFA requirements. We shall assist you to obtain the FEI number which is mandatory requirement for GDUFA self identification of your facility. We just don’t submit your self identification, … Continue reading Our Services for GDUFA Self Identification Requirement
Our standard US Agent fee is $299 for one year. However, if your company has potential regulatory submissions which might include NDA, IND, ANDA, Controlled Correspondence, or PMA, then fees may be more, as these services require more frequent involvement of the US Agent. For food and dietary supplements companies, US Agent fees are $299. … Continue reading How much is the US Agent fee?
US Agent Responsibilities. Acting as an intermediary for communications between the FDA and foreign companies. Provides assistance to answer any questions concerning the foreign establishment’s devices that are imported or offered for import into the United States Assists the FDA to schedule inspections of the foreign establishments Acts as a representative for the foreign company, and … Continue reading What are the responsibilities of a US Agent?
No. Our fees are transparent and there are not hidden charges.
US Agent appointment is mandatory for all foreign companies who wish to market their drug, food or medical device products in the United States. In the vast majority of cases, the FDA communicates with companies through the US Agent.
We can complete the US Agent appointment formalities in just 20 minutes, using through our online system. As soon as you provide your company information and make the payment, we can give you US Agent details to include in your regulatory submission or registration. Click here to sign our US Agent contract. If you are a drug … Continue reading How much time will it take to appoint a US Agent?
Under the law, cosmetics manufacturers are not required to register their cosmetic establishments or file their product formulations with the FDA, and no registration number is required to import cosmetics into the United States. However, we encourage cosmetic firms to participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP) using the online registration system.
Yes. The FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and to determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
This depends on the type of medical device you are intending to market. The FDA has established both general requirements and special requirements. General requirements include establishment registration, device listing, proper labeling and GMP, which are applicable to most devices. Special requirements – such as Pre market notification and Pre market approval – are applicable to … Continue reading What are the requirements for marketing medical devices in the United States?
Pragmatic supports companies to classify their medical devices and identify the applicable regulatory requirements. Our complete solution takes through each stage of the requirements.
You should self identify if you are performing generic drug-related activities, including manufacturing, testing, or clinical studies. It is more important to know when you should self identify. Our services can save you time and money.
With our support, the self-identification process takes about 48 hours.
The FDA publishes a list of all self-identified facility addresses, along with their type of business.
Basic contact information is required, along with information about the nature of the operations – for example, FDF manufacturing or API manufacturing testing.
Only facilities that manufacture, or intend to manufacture, generic drug APIs, FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or re-labelling are not required to pay a user fee.
All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.
Our fees for drug listing are $250.
Our fees for NDC number assistance are $199.
For drug listing, we need the following information: Product label Labelling information Packaging configuration FEI number
We provide a complete service for drug listing and NDC numbers. We will support you through each stage of the process, until your registration is complete.
Once we have the information, the process takes two to three days.
This process takes around 48 hours.
The owner or operator of an establishment entering into drug manufacture or preparation.
What is NDC Number (National Drug Code) ? NDC number is 10 digit numerical code assigned to drugs. First 5 digits of the NDC number come from the labeler code. Labeler code is assigned by the FDA to manufacturer , distributor or brand owner of the product. The first step for NDC number is to obtain … Continue reading What Is NDC Number?
Drug listing is the process of providing product and labeling information to FDA in electronic format.
This is the number assigned by the FDA to the manufacturer /packer/labeler of the drug.
Establishments must renew their registration annually, between October 1st and December 31st of each year.
We prepare the establishment registration SPL on behalf of your company and submit to the FDA through our ESG gateway. We also provide US Agent services for non-US companies.
The FDA does not charge any fee for Establishment Registration. See our pricing section for consulting fees.
Generally, it takes two to three working days.
No. The FDA does not issue any certificates. You can verify your company registration at the below link: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
The contact address and DUNS number are required for Establishment Registration. Non US-companies are also required to provide US Agent information. If required, we can act as US agent for your company.
As per 21 CFR 207, domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.
If all the submitted information is appropriate and correct, the process takes between 12 and 16 months. If you have any other questions about ANDA, please feel to contact us.
ANDA fee for FY 2019 are as below. ANDA fee – $ 178,799 . This fee is applicable for each ANDA. ANDA Program fee – This is the annual for ANDA holder. Large Size $ 1,862,167 Medium Size $ 744,867 Small Size $ 186,217 Large: 20 or more approved ANDAs; Medium: between … Continue reading How much is ANDA fee?
Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.
A generic drug is identical–or bio equivalent–to a brand name drug (already approved by FDA) in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Any companies interested in obtaining generic drug approval should file ANDA.
ANDA is the Abbreviated New Drug Application, the FDA’s generic drug approval process.