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Change of U.S. agent FDA -How it will impact ? October 7, 2020

Change of U.S. agent FDA Change of U.S Agent will not affect your registration or business. You can change the U.S Agent name in the FDA registration anytime. How to change US Agent information in the FDA registration? Login to your account Update information in the US Agent section Submit the registration US Agent will … Continue reading Change of U.S. agent FDA -How it will impact ?

How to get NDC number September 27, 2020

Step by step guide on how to get NDC number.  The first step to get the NDC number is the labler code application. Drug establishment registration. Manufacturing /packaging facilities must be registered with the FDA. Drug listing SPL submission How much time it will take to get the  NDC number? It will take about ten … Continue reading How to get NDC number

FDA approval process and FDA certification September 17, 2020

FDA approval process and FDA Certification What is the FDA approval process or FDA certification?   The answer to this question depends on your product category. Here are the  FDA approval requirements for each category of products i.e., Food, Drug, Medical Device, and Cosmetics.   What is FDA certification? There is no such process or … Continue reading FDA approval process and FDA certification

FDA hand sanitizer registration, FDA requirements for hand sanitizer or   FDA  approval for hand sanitizer ; What is required? September 16, 2020

FDA  approval for hand sanitizer – FDA approval is not required for OTC hand sanitizers. If you are planning to market  Alcohol or Benzalkonium based hand sanitizer, you have to comply with  FDA requirements for hand sanitizer listed below. Drug establishment registration US Agent appointment  (for foreign companies) Obtain a labeler code   Drug listing Compliance … Continue reading FDA hand sanitizer registration, FDA requirements for hand sanitizer or   FDA  approval for hand sanitizer ; What is required?

How to get US FDA approval for Hand Sanitizers April 27, 2020

Here is the answer to your question How to get US  FDA approval for Hand Sanitizers. FDA  approval is not required for over the counter hand sanitizers. You can sell hand sanitizers by complying with “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry”.   You … Continue reading How to get US FDA approval for Hand Sanitizers

What information is required for registration and listing ? May 18, 2020

  For establishment registration–  Company Name , DUNS, Physical address, contact person information    For drug listing – Proprietary name, Active /inactive names, Information about pack /pack type, representative  image of the product label and name and DUNS number of the manufacturer. 

When a new NDC is required ? May 18, 2020

New NDC is required for ; New strength or new active ingredient New Dosage form  Any change in physical appearance (size, shape, color, scoring, imprint, etc.)   Changes to inactive ingredients  Change in proprietary  name 

Who is required to appoint a US Agent?  What are the responsibilities of a US Agent? May 18, 2020

It is mandatory for foreign companies to appoint a US Agent for FDA communication purposes.  The US Agent acts as a medium of communication between the FDA and the Foreign company.

Does FDA issue certificates  upon completion of the successful  registration and listing  process ? May 18, 2020

No, the FDA does not issue the certificate. Registration /listing status can be verified on the FDA website.  If required,  we can issue the certificate for your confirmation. 

Are surface disinfectants regulated by the FDA ? May 18, 2020

  No, surface disinfectants are regulated by the EPA.

Is there a seperate fee for each pack size listing ? May 18, 2020

  No, we can cover multiple pack sizes under one fee .

Is FDA prior inspection required for Hand Sanitizer manufacturing facilities ? May 18, 2020

FDA’s Temporary policy for hand sanitizers  does not mention about the  facility inspection. However, manufacturing should be under sanitary conditions.  For  OTC Hand Sanitizer that  does not comply with FDA’s temporary policy , manufacturing  should be under GMP (Good Manufacturing Practice) conditions , However, prio inspection from FDA is not required, FDA may inspect your … Continue reading Is FDA prior inspection required for Hand Sanitizer manufacturing facilities ?

Who is a private label distributor (PLD) ? May 18, 2020

A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.

NDC numbers are required on the product label ? May 18, 2020

21 CFR 201.2 currently states that NDC’s are “requested but not required” to appear on all drug labels    

What is the labeler code and drug listing  ? May 18, 2020

  You can find more information about    https://www.fdabasics.com/our-faq/ndc-number/

Who is required to obtain the labeler code ? May 18, 2020

Labeler code is a 5 digit number assigned by FDA for each company.  Manufacture, Packer  and Private label distributor are required to apply for the labeler code for drug listing purpose.  

Who is required to register (Drug Establishment Registration) ? May 18, 2020

Drug establishment registration  is  applicable  for manufacturing facilities. Any Establishment engaged in the manufacture, preparation, propagation,compounding, repacking, relabeling, or processing of a drug product for commercial distribution is required to register with FDA. Private label distributors and importers are not required to register.

What is FDA’s temporary policy for hand sanitizers? May 18, 2020

The FDA’s temporary policy  defines several conditions which alcohol based hand sanitizers must follow.  FDA defined conditions include the following ;    Quality and source of  alcohol  Active and inactive composition  Product composition  Testing requirements  Labeling requirement    Manufacturing in sanitized condition with well maintained equipment   Establishment  registration and drug listing Specific dosage form (liquid only) … Continue reading What is FDA’s temporary policy for hand sanitizers?

How can FDAbasics help you ? What is the time and cost?  May 18, 2020

We offer below services to comply with FDA requirements for Hand Sanitizers. US Agent services– Appointment of US Agent is mandatory for foreign companies. Our fee for US Agent services is $ 299 per year. You can complete an  online form at the link below and make the payment.  After receipt of the completed form … Continue reading How can FDAbasics help you ? What is the time and cost? 

FDA regulation for hand sanitizers. How are consumer hand sanitizers regulated in the USA ? May 18, 2020

FDA regulation for hand sanitizers finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for review under the FDA’s OTC Drug monograph system.    FDA regulation for hand sanitizers reaffirms the requirement of additional safety and efficacy data on three other active ingredients (benzalkonium chloride, ethyl alcohol, … Continue reading FDA regulation for hand sanitizers. How are consumer hand sanitizers regulated in the USA ?

Test Form November 13, 2019

FDA cosmetic labeling requirements FDAbasics November 1, 2019

Overview of  FDA cosmetic labeling requirements   Here is a list of  FDA cosmetic labeling requirements The common name of the product must be displayed prominently on the principal display panel. Example “Moisturizing cream” New weight should appear prominently on the PDP Cosmetic Ingredient labeling; all the ingredients used  (except flavors and fragrances) must appear … Continue reading FDA cosmetic labeling requirements FDAbasics

What is FDA DMF ? US FDA DMF Filing October 31, 2019

FDA DMF   filing requirements (Drug Master File) DMF stands for Drug Master File which contains confidential information related to the manufacturing, control  or chemistry of the product.  A US DMF filing is the provision made by the US FDA  to maintain the confidentiality  of the information in the DMF Filing. The Manufacturer of the Drug, … Continue reading What is FDA DMF ? US FDA DMF Filing

FDA Drug listing requirements for API (bulk drugs) October 18, 2019

Drug establishment registration and  drug listing are mandatory requirements for APIs  (bulk drugs) commercially marketed in the USA.  Manufacturer of API must register their  drug  establishment  where the product is  manufactured, packed or  processed and list all the drugs  which are in the commercial distribution. What  information is required for   API drug listing ? Below … Continue reading FDA Drug listing requirements for API (bulk drugs)

An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs September 26, 2019

FDA requirements for OTC drugs vary for  OTC monograph products and new  OTC drugs. Drugs  with active  ingredients published in the OTC final monograph which   can be marketed  without prior approval from FDA. However,  if you are planing to  market OTC   drugs  with active ingredients which are not part of the  OTC monograph you should … Continue reading An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs

US FDA labeling requirements for food September 24, 2019

Here is the summary of  FDA labeling requirements for food products marketed in the USA. Overview of US FDA labeling requirements for food The product should bear a statement of identity (common name of the product) more prominently on the principal display panel. Net weight should appear both in US customary and metric systems ( … Continue reading US FDA labeling requirements for food

US FDA Registration is required for your product ? Understanding US FDA Registration Requirements, a complete guide for US FDA compliance. September 19, 2019

Manufacturer of  Food, Drug, and Medical device requires US FDA registration for their facilities. US FDA Registration is only needed if you are planning to market your products in the USA.    FDA registration vs. FDA approval   The term  “US FDA registration” or “FDA Registration” is often confused with the term  “FDA approval.” However, FDA … Continue reading US FDA Registration is required for your product ? Understanding US FDA Registration Requirements, a complete guide for US FDA compliance.

What should you know about DMF annual report September 17, 2019

In the  industry there  is  lot of confusion  about  content and format of   DMF  annual report. Important  –  DMF annual reports are  NOT used for   reporting changes in the drug master file. Amendments  are used for reporting changes in the DMF. Contents of  DMF annual report.  1.Cover letter – Annual report should contain the  formal … Continue reading What should you know about DMF annual report

How to search FDA registration number September 13, 2019

Answer to the question “How to  search FDA Registration Number”  depends on the type of product.  FDA has maintained the database for  medical device and drug establishment registrations, whereas there is no online searchable database for food facility registration. Here are the step by step instructions  to search FDA Registration Number   1. Food Facility … Continue reading How to search FDA registration number

How to Renew FDA Registration – Timelines and Fees September 10, 2019

 FDA registration renewal timelines?   The answer to this question depends on whether your product is Food, Medical Device, or Drug. Food facility registration  renewal   Food facility registration must be renewed every even year between 1st October to 31st Decemebr. For example, in 2018, 2020, and 2022.  We offer free assistance for food facility registration … Continue reading How to Renew FDA Registration – Timelines and Fees

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

US FDA food regulations March 8, 2017

Here is a summary of US FDA food regulations. However, additional requirements are applicable based on your product category. Appoint a US Agent (for all foreign companies) Food facility registration  FDA labeling requirements  Food Safety  (HACCP or GMP) Prior import notice Compliance with product-specific requirements, if any Please click here for detailed information. FDAbasics can … Continue reading US FDA food regulations

FSVP Agent (FSVP Importer) – FSVP requirements 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) – FSVP requirements

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 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 be … Continue reading FDA Biennial Registration Renewal period Food Facility

What is FSVP ? February 10, 2019

FSVP stands for the Foreign Supplier Verification Program. FSVP is one of the requirements as per the FSMA rule, which requires importers in the United States to verify their foreign suppliers to ensure their suppliers follow food safety standards equivalent to the standards established by the FDA.    As per the FDA’s FSMA  rule, foreign … Continue reading What is FSVP ?

What are the FDA requirements for food- USA Food regulations January 21, 2019

FDA requirements for food- USA Food regulations     FDA regulates foods and food ingredients sold in the USA, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).   1. Food Facility Registration Food facility registration is one of the  FDA requirements for food products. If you … Continue reading What are the FDA requirements for food- USA Food regulations

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

Responsibilities of US Agent March 7, 2017

Below are the  Responsibilities of US Agent Acting as an intermediary for communications between the FDA and foreign companies. Provides assistance to answer any questions concerning the foreign establishment is one of the crucial responsibilities of US Agent.   Assists the FDA to schedule inspections of the foreign establishments  Acts as a representative for the foreign company, … Continue reading Responsibilities of US Agent

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 … Continue reading How much is the US Agent fee?

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?

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.

Are there any hidden fees? March 7, 2017

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

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 an NDC Number? FDAbasics.com – Drug Listing December 7, 2016

What is an NDC Number (National Drug Code) and Drug Listing? NDC number format explained.  NDC  number is a ten-digit numerical code assigned to drugs. The first five digits of the NDC come from the labeler code.  The FDA assigns labeler code to the manufacturer, distributor, or private label distributor of the product.   The first … Continue reading What Is an NDC Number? FDAbasics.com – Drug Listing

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 an NDC labeler code? FDAbasics December 7, 2016

What is an NDC labeler code, and how to get it?    NDC  Labeler Code is a five-digit number assigned by the FDA to firms intended to market/manufacture the drug. Labeler code constitutes the first five digits of the NDC number. After obtaining an NDC labeler code from the FDA, the firm can submit the … Continue reading What is an NDC labeler code? FDAbasics

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: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

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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