Services to Ease FDA Regulatory Compliance


eCTD Requirements and cost effective solutions February 17, 2019

 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

How can I market food products? March 8, 2017

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?

FSVP Agent (FSVP Importer) February 10, 2019

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)

FDA Biennial Registration Renewal period Food Facility September 15, 2018

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

What is FSVP ? February 10, 2019

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 ?

What are the FDA requirements for food January 21, 2019

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

Does each food or dietary supplement require separate registration? March 8, 2017

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.

How much time is required for food facility registration? March 8, 2017

After you have provided the required information, it takes about 48 hours to complete the food facility registration.

How we can assist you? March 8, 2017

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.

How much is the DMF Fee ? March 8, 2017

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 ?

How much time is required for DMF submission? March 8, 2017

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?

How we can assist for DMF submission to FDA? March 8, 2017

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.

What is a Drug Master File? March 8, 2017

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.

Our Services for GDUFA Self Identification Requirement March 7, 2017

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

How much is the US Agent fee? March 7, 2017

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?

What are the responsibilities of a US Agent? March 7, 2017

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?

Are there any hidden fees? March 7, 2017

No. Our fees are transparent and there are not hidden charges.

Do I need a US Agent? March 7, 2017

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.

How much time will it take to appoint a US Agent? March 7, 2017

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?

FDA US Agent March 7, 2017

What do cosmetics firms need to do? December 7, 2016

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.

Can the FDA inspect cosmetics manufacturers? December 7, 2016

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.

What are the requirements for marketing medical devices in the United States? December 7, 2016

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?

How we can help to market your medical device? December 7, 2016

Pragmatic supports companies to classify their medical devices and identify the applicable regulatory requirements. Our complete solution takes through each stage of the requirements.

When Should I Self-Identify? December 7, 2016

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.

How much time will it take to self-identify my facility? December 7, 2016

With our support, the self-identification process takes about 48 hours.

How can I very my self-identification status? December 7, 2016

The FDA publishes a list of all self-identified facility addresses, along with their type of business.

What information is required for self-identification? December 7, 2016

Basic contact information is required, along with information about the nature of the operations – for example, FDF manufacturing or API manufacturing testing.

What about fees for self-identification? December 7, 2016

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.

Who needs to self-identify? December 7, 2016

All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.

What are your fees for drug listing? December 7, 2016

Our fees for drug listing are $250.

What are your fees for NDC assistance ? December 7, 2016

Our fees for NDC number assistance are $199.

What information do I have to provide for Drug Listing? December 7, 2016

For drug listing, we need the following information: Product label Labelling information Packaging configuration FEI number

How can you help me with Drug Listing? December 7, 2016

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.

How much time will Drug Listing take? December 7, 2016

Once we have the information, the process takes two to three days.

How much time does it take to obtain the NDC number? December 7, 2016

This process takes around 48 hours.

Who needs a Drug Listing? December 7, 2016

The owner or operator of an establishment entering into drug manufacture or preparation.

What Is NDC Number? December 7, 2016

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?

What is a Drug Listing? December 7, 2016

Drug listing is the process of providing product and labeling information to FDA in electronic format.

What is the Labeler Code? December 7, 2016

This is the number assigned by the FDA to the manufacturer /packer/labeler of the drug.

When do we need to renew Drug Establishment Registration? December 7, 2016

Establishments must renew their registration annually, between October 1st and December 31st of each year.

How can Pragmatic help with Establishment Registration? December 7, 2016

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.

What are the fees for Establishment Registration? December 7, 2016

The FDA does not charge any fee for Establishment Registration. See our pricing section for consulting fees.

How long will it take for Establishment Registration? December 7, 2016

Generally, it takes two to three working days.

Does the FDA issue Certificates of Registration? December 7, 2016

No. The FDA does not issue any certificates. You can verify your company registration at the below link:

What information is required for Establishment Registration? December 7, 2016

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.

Who should register? December 7, 2016

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.

What is the time frame for approval for ANDA Applications? December 7, 2016

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.

How much is ANDA fee? December 7, 2016

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?

What information should be included for ANDA? December 7, 2016

Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.

What is a generic drug? December 7, 2016

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.

Who should file ANDA? December 7, 2016

Any companies interested in obtaining generic drug approval should file ANDA.

What is ANDA? December 7, 2016

ANDA is the Abbreviated New Drug Application, the FDA’s generic drug approval process.

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