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Drugs

       Over-the-counter
       Precription drugs
       Active pharmaceutical ingredients
       Homeopathic drugs

 

ST&T Research can submit New Drug Applications (NDA) or Abbreviated New Drug Applications – Generics (ANDA) to the FDA.

The NDA is the procedure through which drug sponsors formally apply for FDA approval for a new pharmaceutical product for sale and marketing in the U.S. With the NDA, drug sponsors must provide enough information to FDA to prove the drug is safe and effective in its proposed use(s), and the benefits of the drug outweigh the risks. Drug technical data must be submitted with the NDA.

Abbreviated New Drug Applications (ANDA) must scientifically demonstrate that the product is bioequivalent to the innovator drug.

ST&T can assist you in gathering and preparing all the information required to submit a NDA or ANDA as well as submitting the application for the new drug listing and drug establishment registration.

We can also assist you in the design or review of the labeling to make it comply with the FDA requirements. If necessary, we can review the methods used in drug manufacturing as well as the quality control in order to comply with the cGMP’s for drug manufacturing facilities.


 

OTC - Over-the-Counter

An over-the-counter (OTC) drug must be recognized as safe and effective, it must meet  the FDA regulatory requirements as well as the conditions contained in any applicable monograph. ST&T Research Intl can assist you in properly register your product(s) avoiding fail to conform the FDA requirements.

1. Registration

     - Drug Establishment Registration
     - Drug listing Information
     - List another OTC Drug
     - Update registration information

2. Labeling and ingredient review

    Ingredient compliance design and review
    Label compliance design and review
    Packaging compliance design and review

3. Certificate of registration

4. US Regulatory Agency

The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.

Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.

5. Transfer old submissions to the new FDA electronic system

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. ST&T can transfer your Drug Establishment Registration and Drug listing Information to the new electronic system.

 

 

PRESCRIPTION DRUGS

1. Registration

   - FDA Establishment Registration
   - Drug listing and label submissions
   - Update Prescription drug and listing information

2. Labeling and ingredient review

   - Ingredient compliance design and review
   - Label compliance design and review
   - Packaging compliance design and review

3. Certificate of registration

4. US Regulatory Agency

The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.

Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.

5. Transfer old submissions to the new FDA electronic system

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. ST&T can transfer your Drug Establishment Registration and Drug listing Information to the new electronic system.

 

 

ACTIVE PHARMACEUTICAL INGREDIENTS (API)

1. Registration

   - FDA Establishment Registration
   - Drug listing and label submissions
   - Update Prescription drug and listing information

2. Labeling and ingredient review

   - Ingredient compliance design and review
   - Label compliance design and review
   - Packaging compliance design and review

3. Certificate of registration

4. US Regulatory Agency

The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.

Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.

5. Transfer old submissions to the new FDA electronic system

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. ST&T can transfer your Drug Establishment Registration and Drug listing Information to the new electronic system.

 

 

HOMEOPATHIC DRUGS

According to the US FDA Regulation, those products that are offered for treatment of serious disease conditions, must be registered as prescription drugs. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC. ST&T Research Intl can assist you in properly register homeopathic drugs and establishments as well as adequate the labeling and packaging to comply with the US FDA requirements. 

1. Registration

   - FDA Establishment Registration: all firms which manufacture, prepare, propagate, compound, or otherwise process homeopathic drugs must register as drug establishments in conformance with Section 510 of the Act and 21 CFR 207.

   - Drug listing and label submissions: homeopathic drug products must be listed in conformance with the Section 510 of the Act and 21 CFR 207.

   - Update Prescription drug and listing information   

2. Labeling and ingredient review / design

Homeopathic drug product ingredients, labeling and packaging must comply with the provisions of the US FDA for homeopathic drugs. In ST&T Research Intl we can assist you in properly label and package your products.

   - Ingredient compliance design and review
   - Label compliance design and review
   - Packaging compliance design and review

3. Certificate of registration

4. Registrant Contact Designation

5. US Regulatory Agency

The US FDA & CUSTOMS (and most other importing countries) require that any domestic or foreign manufacturer and/or distributor who ships into/out of the country must have a local agent who can respond to FDA NDC filing/reporting, and Customs, legal and regulatory matters or questions which may arise concerning their products. ST&T has specialists who provide clients with these Regulatory Agent Services.

Acting as your U.S. Agent, your Company will be provided legal & science support for its efforts to market products in the USA.

6. Transfer old submissions to the new FDA electronic system

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. ST&T can transfer your Drug Establishment Registration and Drug listing Information to the new electronic system.

 

 




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