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FDA Registration

Who is required to  comply with  FDA registration  requirements?

Companies involved in  the manufacturing, processing  or packing of  Drug, Medical Device or  Food  are required to register with FDA .  However,  FDA registration requirements  vary based  on the operations performed by the establishment.

1. Drug Companies (OTC, Prescription, Bulk Drugs,  Pharmaceutical Testing  facilities)

Drug establishment registration requirement is applicable to facilities  engaged in the manufacturing , repacking, relabeling, or salvaging of a drug product for commercial distribution .  FDA does not charge any fee for drug establishment registration.

Foreign facilities are required to appoint U.S Agent for drug establishment registration purpose.  Pragmatic  Compliance  LLC  offers U.S Agent service and establishment registration, you can find more information in our services section. Our fee for establishment registration including one year U.S Agent services is $  500.

Companies are required to complete  initial registration with   5 days of introducing product into commercial distribution. Drug establishment  must be renewed   between October 1 and December 31 of each year.

2.  Medical device establishment registration device listing

FDA has published the chart which will help you to understand  registration requirements.

Further, medical device facilities are also required to pay FDA annual fee.  You can check FDA fees for the current fiscal year at the below link.

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm

Foreign companies are required to appoint U.S Agent for medical device registration and listing  purpose. Our annual fee for U.S Agent services is $ 299 (valid for 12 months from the date of  the fee payment).  We can also assist you for establishment registration and device listing. Our fee for registration and listing assistance is $ 199 (which includes fees for listing of 10 devices).

You can complete our online medical device registration form and make the payment. It will take two working days to complete the medical device facility registration and device listing  after receipt of PCN number from FDA.

Please contact us for more information.

3. Food Facility Registration (Conventional  Foods and Dietary Supplements)

Food  facilities (establishments),  where food is manufactured, packed , processed or stored are required to register  the food facility . Establishment engaged in the distribution , trading or retail business are not required to register with FDA.

You can find retail establishment exemption  flow chart at the below link.

https://www.fda.gov/downloads/Food/GuidanceRegulation/FoodFacilityRegistration/UCM608069.pdf

Foreign  food facilities  are required to appoint U.S Agent for  food facility registration purpose.  We can act as your U.S Agent and register the food facility. Our fee for U.S Agent services including food facility registration is $ 299.  You can complete our online food facility registration form.  It will take two working days to get the food facility registration number.

If you have any other questions, please contact us. 

 

Food Facility Registration Renewal

Biennial Food Facility Registration Renewal Requirements

All  the registered  food facilities are required to renew their registration every even year between October to December, for example if you completed  food facility registration in the month of July 2017, your registration renewal  will be due in the month of December  2018 ,  which you can renew between  October to December 2018  . Your next renewal  will be  due in the month of December 2020.

Pragmatic Compliance offers free  services for food facility registration and renewal  for our clients with active U.S Agent contract with our company. You can  find  more information about our U.S Agent services at  U.S Agent information page.

Pragmatic Compliance  offers U.S Agent services at lowest fees.  You can  sign U.S Agent contract with our company online.

If your initial food facility  registration is  not submitted by  our company then you may have to provide your Food Facility Registration number and PIN number to  renew your food facility registration. If you do not have the access to you facility registration  PIN number ,  our company shall assist you to obtain the PIN number  from FDA.

We can renew your food facility registration renewal within 24 hours  from the time of your request.

Our fee for  domestic food facility registration renewal is $ 159.

If you have any questions or need more information about food facility registration renewal services , please contact us. 

We offer guaranteed lowest  prices and quality services 

US Agent for Medical Device Companies

US Agent for Medical Device companies.

All the foreign medical device companies  who are required to comply with FDA registration requirements should appoint U.S Agent for communication with FDA.  US Agent acts acts as medium of communication between FDA and foreign company.

Pragmatic offer services to act US Agent for Medical Device companies.

Responsibilities of US Agent for Medical Device companies.

The responsibilities of the U.S. agent are limited and include:

  • assisting FDA  to communicate with the foreign establishment,
  • responding to questions related to  foreign establishment’s devices that are imported or offered for import into the United States,
  • assisting FDA for  foreign establishment inspection scheduling
  • incase, FDA is unable to contact the foreign manufacturer , FDA may contact U.S Agent for regulatory communication purpose.
  • Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

Pragmatic Compaliance offer U.S Agent services to foreign companies at competitive  fees. Our fee for U.S Agent services is $ 299 for 12 months.

We do not hike prices during annual renewal or charge any other hidden fees. All prices are upfront.  We confirm FDA  US Agent notifications immediately.

Along with U.S Agent services , we also offer medical device registration and listing services.

Complete our online U.S Agent form to sign U.S Agent contract.

FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING

Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format, These changes include any drug recently introduced in the U.S. commercial distribution which was not previously listed, any drug which commercial distribution has been ceased, any drug reintroduced in commercial distribution and any material changes in any drug listing information previously submitted.

 

After initial electronic listing, registrants may satisfy the listing certification requirement with respect to unchanged listing information by submitting annual blanket no changes certification of product listing.

At the time of the annual registration update under Sec.  207.29(b), a registrant may submit a blanket “no changes” certification covering all of its listed drug products for which no changes to reported listing information were made since the last annual registration update or listing submission. This blanket certification applies only to drug listing information that has been submitted electronically.

Any NDC which has not been newly submitted or updated during the calendar year, or certified during the October to December registration renewal period will be considered expired on January 1st of the following year. All expired listings will be removed from publication in the NDC Directory  and if you fail to comply with these requirements your products will be considered as adulterated and misbranding.

We, at pragmatic offer No Change Certification for product listing. We offer these services for  $ 299 for 10 products no change certification, for each set of additional 10  products $ 25 fees is applicable. 

Contact us  to complete no change certification in 48 hours. 

 

 

 

self identification for FY 2018

FDA’s self identification period for fiscal year 2018  starts from 1st May 2017 and all the facilities involved in generic drug submission are  required to submit, update or re-confirm the self identification on or before 1st June 2017. CDER has started to send  email with below content to all the facilities  who have self identified  in the previous  year.

“Submit, Update, or Reconfirm Self-Identification Information to the Food and Drug Administration (FDA) for Fiscal Year (FY) 2018.

“Greetings,

The FY 2018 generic drug facility self-identification open reporting period will begin on May 1, 2017, and run until June 1, 2017.”

We at  Pragmatic  offer complete assistance for GDUFA self identification submission to FDA. It is important to understand the classification of your facility whether its CMO or non CMO based which GDUFA fees are applicable.

If you need any assistance on GDUFA self-identification or if you have any questions please contact us.

what you should know about GDUFA II

In the month of August  FY 2018 fees for generic drug application will be published,  which will be based on GDUFA II. We have summarized highlights  of GDUFA II fee structure and how it will benefit small business.

 GDUFA II Highlights  

No fees for  ANDA supplement fees

No facility fees for manufacturing  facilities with unapproved ANDA

If you are just contract manufacturer and do not have affiliation with any ANDA holding  organization then you will pay only one tenth of  proposed  facility fees.

 

Now ANDA sponsor companies  will pay fixed annual ANDA Sponsor Program fee which depends on the number of ANDAs owned by companies. ANDA fees are divided in three tiers. small, medium and big.

  • Large (companies with 20 or more approved ANDAs);
  • Medium (companies with between 6 and 19 approved ANDAs); and,
  • Small  (companies with 5 or fewer approved ANDAs).

Facilities  which manufacture   both API and FDF will only pay FDF facility fee, as per GDUFA I both API and FDF fees were applicable to such facilities.

GDUFA II has brought relief to small companies who have no approved ANDA , they need not pay the facility fee until ANDA is approved. Once ANDA is approved facility  is applicable from next fiscal year irrespective whether product is in commercial distribution or not.

GDUFA II has also brought  big relief  to contract manufacturing organizations (CMO)   who just manufacturer the product for another ANDA sponsor and do not hold ownership of other  ANDAs or affiliated with companies who own ANDAs  .

If you have any question on GDUFA II fee program please contact us.

U.S Agent Terms and Condition

Pragmatic is private consulting firm and offers U.S Agent services to many companies. Pragmatic is not affiliated with FDA. By accepting this agreement, Pragmatic and Company agree to following terms. Company means the receiving party of services

Pragmatic is acting as U.S Agent for Company to facilitate the communication between  FDA (US Food and Drug Administration) and is only responsible for transmitting the information received from FDA to Company, unless specific service agreement exists..

U.S Agent agreement between Company and Pragmatic will remain effective for 12 months from the date of payment. Unless extended, this is the period specified.

U.S Agent fees do not include any other consulting or any regulatory work unless jointly agreed to by both parties.

Company warrants that information provided in this form is Truthful and Accurate. It remains Companies responsibility to update any change in the provided information.

Company acknowledges that Pragmatic is acting as U.S. Agent between the Company and the Food and Drug Administration and has no involvement or specific knowledge of the Company’s products.

Company will not hold Pragmatic liable for any negligence and/or damages whatsoever including but not limited to any liability arising with respect to the performance of the Company’s products.

Neither party to this contract shall be held responsible for breach of contract caused by an act of God, insurrection, civil war, military or local emergency, or by any act or failure to act by the U.S. Food and Drug Administration.

In case of any breach of terms Pragmatic has right to terminate the services with seven days advance notice. In case of non-payment for renewal of services   Pragmatic may revoke all the provided services  such U.S Agent appointment , registration, listing or any other such services and Pragmatic will not be responsible for any loss faced by Company as result of such action.

Pragmatic shall inform Company seven working days before taking any such actions.

Pragmatic offers the most competitive pricing without compromising quality and any such statements regarding our pricing are not legally binding. However, we welcome our customer’s feedback on pricing and shall try to meet their expectations.

Customers confidentiality is top most priority for Pragmatic and Pragmatic will not intentionally disclose any confidential information to third parties unless mutually agreed to by Pragmatic and Company or required by the law.

 

FDA Establishment Registration Fees

Our  FDA establishment registration fees is $ 299 there is no hidden . Our services include complete assistance for the following.

  1. Assistance for obtaining DUNS number
  2. Creating establishment registration
  3. Submission of establishment registration to FDA through our ESG
  4. Assistance for obtaining FEI number
  5. Complete assistance till establishment  registration appears on FDA website.

We offer guaranteed lowest price  with quality services.  We offer best quality and price challenge on all our services. 

FDA does not charge any fees for drug facility registration and its free . FDA also does not offer the certificate of registration, companies  can verify the successful  registration on FDA website.  Understand more about establishment registration.   In  order complete establishment registration fill our drug establishment registration form  or you can contact us.

How to market food products in US

In order to market food products you have comply following requirements.

1, Foreign companies  required  to appoint US agent

2. Establishment Registration

3. Labelling

4. GMP manufacturing

5. Prior import notice

Pragmatic can offer you all guidance and required services at lowest fees with quick turn around time. Contact us for more information.

 

FDA’s Mandatory eCTD requirements ? Are you ready ?

eCTD !

From the beginning of  May 5, 2017,  FDA requires, ANDA, NDA, and Master Files regulatory submission in eCTD  format.

Since FDA is mandating electronic submission  requirements from May 5, 2017 for all the  future amendments, annual reports , supplements or any such regulatory filings. But, its not mandatory to convert all previous submission in electronic format.

Handling regulatory submission in electronic  format requires  trained professionals and software for  XML conversion. Moreover, eCTD submission is challenging  process considering FDA’s eCTD  validation requirements.

Electronic regulatory  submission involves  systematic  planing , document structuring  and complying to various requirements. eCTD publishing is crucial work since  small mistake may lead to refusal to recieve submission.

eCTD Publishing Services

We at Pragmatic  offer complete solution for  eCTD publishing   of ANDA, NDA and all types of drug  master files including submission  through  our ESG account.   Unlike other companies we just do not convert your submission to eCTD , but we will also assist you locate the documents within  proper sections of eCTD.

Our regulatory experts have in depth knowledge and experience  in handling electronic submissions , with our services you need not to worry about document format, XML conversion or even templates for amendment, annual report or any such regulatory submission, We offer electronic submission services for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs), and master files at competitive fees with highest quality services.

Our  fees for  eCTD publishing  starts from as low as $ 329 which depends on the type of application and regulatory submission. Please contact us for more information.

Why Pragmatic  ?

With our services you will get one stop solution for all your regulatory requirements such as US agent service, establishment registration, NDC number, GDUFA self identification, gap analysis   or any other regulatory consulting services. Our services include complete support till acceptance of your regulatory application.

ectd requirements

FDA Self Identification For The Year 2016 Started.

As required by Generic Drug User fee act FDA self identification period  for fiscal year  2016 starts on May 1s  2015, and companies can self-identify their facilities till  June  1st ,2015.

Companies who are into generic drug Manufacturing, Testing. Packaging or  Conducts Bioequivalence /Bio analytical study are required to self-identify with FDA by providing the information type of operation they perform such as manufacturing, API manufacturing , testing, etc..

Self-identification process helps FDA to calculate the estimated GDUFA fees for upcoming fiscal year.

Not all the facilities who self-identify are not required to pay the GDUFA fees, only facilities who manufacture or intend to manufacture the finished product or API are required to pay the GDUFA fees.

Failure to self-identification is violation of federal law and may results disciplinary action by FDA.

Tobias Systems can assist companies to self-identify your facilities at the lowest fees and also  provide whether self-identification for  your facility is required or not.

If you have any questions  on self-identification please write to us .

FDA Conslutants

Pragmatic  Compliance   has many years of experience as FDA consultant, we provide FDA consulting services for food, drug, medical device, cosmetic and plastic companies. We understand that , aim of all the regulatory compliance is to bring your products to the markets, so aim of our consulting is to bring your products in to market faster without any major regulatory obstacles. We have discussed here about few points which you consider before hiring any FDA consultants.

Why FDA Consultant ?

NDC Number Format

What is NDC Number format ?

NDC (National Drug Code) is 10 digit number which is grouped in three sets. First set of five or six digits corresponds to labelar code, which FDA assigns to the labelar, such labelar code identifies the labelar or responsible owner of the drug. Labelar can be any company who performs operations such as manufacturing, packing or distributor of the products. Second set of  NDC number is product specific, so labelar has to assign   three or four   digit product code  for each drug  they manufacture or distribute. Product code should be unique for each product, drug products  with same active having different  strength or formulation will be  considered as different products.  Last set of NDC number corresponds to pack code, which should identify the pack size and pack type. So, NDC number format is 10 number digit set of   4-4-2, 5-3-2, or 5-4-1.

Example of NDC number format

If a company manufactures  Drug A having 25 mg  and 50 mg strengths in two pack sizes of 50’s and 100’s count, then NDC number will be as follows.

Consider 12345 , as a 5 digit number as labelar code  assigned by FDA to labelar.

NDC number for Drug A 25 mg of 50 counts :- 12345-678-10

NDC number for Drug A 25 mg of 100 counts :- 12345-678-20                                                                           

NDC number for Drug A 50 mg of 50 counts :- 12345-876-10

NDC number for Drug A 50 mg of 100 counts  :-12345-876-10

NDC number Drug A 50 mg of 10 counts blister :- 12345-876-30

In the above example;

12345 is FDA assigned labelar code

678 is the product code for Drug A 25 mg

876 is the product code for Drug A 50 mg

10 is the pack code for 50  tablets in container

20 is the pack code for 100 tablets in container

30 is the pack code for 10 counts in blister

Tobias provides complete assistance for obtaining the labelar code,  assigning NDC number and drug listing, if you have any questions please write to us.

Drug Establishment Registration Renewal

As per 21 CFR 207, companies who manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S are required to register their facilities and are required to keep the information updated. Companies  who have registered their establishment are also required to renew the drug firm registration  annually . Drug establishment registration renewal period is between October  1st to December 31st period.

Drug establishment registration and renewal is mandatory for US and non US companies, including prescription , OTC and API   manufacturer, testing and packaging facilities.

Failure to  drug establishment registration and  renewal  in accordance with section 510  and 502 of the Act is a prohibited and products manufactured in such facilities will be deemed as misbranded.

Tobias provides assistance for drug establishment registration renewal with  competitive fees. Our fees for establishment registration renewal is $ 250 which includes preparing your establishment registration SPL and submission.

US FDA Regulatory For Approval In Medical Devices

FDA is the established ultimate authority for providing approval for manufacture of import of medical devices in US. The Congress also appoints it to charge certain fees for this work from the license seekers. The fee is not fixed but is determined in the preceding year’s middle months.

The conditions of seeking registration is not that complicated but in present situation must be submitted digitally if prior approval for otherwise is not already given. The registration process is annual and the owner or the manufacturer also needs to furnish some more information like the work carried out in the mentioned establishment, the nature of work of these devices and a complete list of devices manufactured there. This information is particularly vital as knowing a location in national emergency can help the officials to arrange for them at the shortest notice.

So, if you are applying for the first time, remember your establishment details are important; your device and all other medical devices you manufacture are important to mention, it is also important to mention what are the objectives your device is going to serve and if possible do mention the country of manufacture of the device.

Remember there will me lot many categories of devices according to their purpose and use in treatment. So, it is better if you clearly and explicitly detail all the work to perform is better. Some of the devices will have health implications by their nature and caution and care will be necessary to use and transport them. Clearly state the precautions the device needs, it can save lives.

FDA approval is a long process but not that complicated. If you are weighing the possibilities of mistake you can always approach any of the reputed FDA regulatory consultation and assistance companies. Please remember FDA does not approve or appoint any for consultation, their professional experience is the only thing that stands for them. So, choose wisely.

Is Ebola Making FDA Concerned ??

In July ‘14 FDA in their compliance guidance for manufacture of drugs paid added attention to the NTDs. The Neglected Tropical Diseases. Most of these diseases are confined to the developing world and where the surroundings play an important role.

Apart from the medical reasons for these diseases, there are the causes like sanitation, availability of clean drinking water, basic facilities of living like bed nets to protect against insects in sleep, careless behavior of conduct play crucial contributors. The diseases have been there but the response of FDA is quite surprising.

It is quite clearly understood with the facilities and easy initial permissions that FDA is allowing to the manufacturers for setting up facilities to manufacture drugs for such diseases indicates that FDA is taking serious interest in the development of those drugs. Since most of them do not affect the US citizens or US soil it is quite surprising about their interest in developing or taking so much interest to develop the drug.

If we now bring the Ebola angle to this discussion we can comprehend little more about this. Africa, the incubator of this disease is also a hot destination for adventure loving Americans and their inherent immunity in these diseases will be much lower considering their lack of exposure. So, if a single case breaks out it can turn endemic for US. Rather than tackling a serious problem of medical immaturity they are acting smart.

As of today, scientists are already breaking new barriers to find injections of Ebola that are successful on animals. Who knows this was not a direct outcome of the FDA initiatives and the incentives they offered to manufacturers for this drug, though cloaked in a general support and encouragement??

EDQM Updated CEP Revision And Renewal Guideline.

EDQM update their guideline for Revision and Renewal of

CEP.

The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”.

Following are the modifications.

Revised the guidelines according to European guideline on variations to marketing authorisation applications.

The structure of the guidance document  has also been modified.

As a consequence, the document  procedure for revision and renewal management and application forms are updated.

The revised documents have an implementation date of 01 September 2013.

Purple Book For Licensed Biological Products

FDA has published purple book containing list of licensed biological products with reference   product, and biosimilarity.   The lists includes the date on which biological product was licensed under PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.

 

This list will enable to see whether a biological product of users interest is determined by FDA to be bio similar or interchangeable. This list will also provide reference product exclusivity expiry date.

You can find purple book at below link.

 

http://www.accessdata.fda.gov/scripts/opdlisting/oopd/

FDA’s Policy On Communicating Drug Approval Information

FDA’s has made effective manual procedure and policy for communicating drug approval information. Considering interest of industry and FDA including press an other international counter parts FDA will make drug approval information (Approval Letter) available on CDER’s website.

In the  published  manual of FDA  it is mentioned  that,   approval and tentative approval letters for original and supplemental drug  applications will be made available through  CDER’s Web site, generally within three  business days of the approval, for the following categories:
1) NDAs and BLAs (Original application,  efficacy supplement labeling supplements )
2) ANDAs identified by the Office of Generic Drugs (OGD)

Labeling information of approved ANDA (RLD only), NDA and BLA  will be published to CDER’s website  within three days of   approval of labeling supplement.

You can find manual at below link

 

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM078818.pdf