Basic Information Sheet | FDA Facility Registration – Consultare Inc. Group

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FDA Services

Thank you for expressing your interest in working with us in transacting with the US FDA. Kindly go through the questions below. Please do not forget to review your answers before proceeding.

Product Category

Select the category(ies) that best describe the products being handled in your facility. *

Animal Food, Feeds, Drugs, and Related Products
Biologics
Cosmetics
Dietary/Herbal Supplements, Nutraceuticals
Human Food and Food Packaging
Medical Devices
Pharmaceuticals, Drugs for Human Use
Tobacco Products
Others

Others: Please specify. *

Animals

Please check the box(es) that best describe your animal food/feed/drug products. *

Animal drugs (e.g., ophthalmic, oral, injectables/implants, intramammary, topical dosage forms)
Animal feed
Animal food/feed additives
Animal food/drink substances Generally Recognized as Safe (GRAS)
Animal food packaging materials
Medicated feed
New animal drugs
Pet food
Others

Others: Please specify. *

Biologics

Please check the box(es) that best describe your biological products. *

Allergenic products
Arsphenamines and/or derivatives
Biological analogues
Blood and blood components or derivatives
Proteins
Radioactive biological products
Therapeutic serums
Toxins and antitoxins
Viruses
Others

Others: Please specify. *

Cosmetics

Please check the box(es) that best describe your cosmetic products. *

Cosmetic ingredients (e.g., acids, additives, amines, fragrances, parabens)
Hair products
Makeup
Nail products
Soaps and lotions
Tanning products (e.g., tanning pills, self-tanners, bronzers)
Tattoos, henna, and permanent makeup
Others

Others: Please specify. *

Dietary Supplements

Please check the box(es) that best describe your dietary supplements. *

Amino acids (ex., glutamine)
Botanicals or herbs (e.g., ginger)
Botanical compounds (e.g., caffeine)
Live microbials (probiotics)
Vitamins and/or minerals (e.g., biotin)
Others

Others: Please specify. *

What type of food product/s do you offer? *

Human Food and Beverages
Food Packaging

Human Food

Please check the box(es) that best describe your food products. *

Beverages
Bakery Products (ex. brownies, cakes, cookies, crackers, croutone, grain-based bars, pies, waffles)
Cereals and Other Grain Products (ex. rice, oats, wheat)
Dairy Products and Substitutes
Desserts
Desserts Toppings and Fillings
Egg and Egg Substitutes
Fats and Oils
Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes
Fruits and Fruit Juice
Infant and Toddler Foods (ex. dry instant/prepared/ready-to-serve cereal, ready-to-serve cereal dinners/fruits/vegetables/eggs, juices)
Legumes
Miscellaneous Category (ex. baking powder, baking soda, pectin, cooking wine, chewing gum, salt, etc.)
Mixed Dishes
Nuts and Seeds
Oils and Oilseed Products
Potatoes and Sweet Potatoes/Yams
Salads
Sauces, Dips, Gravies, and Condiments
Snacks
Soups
Sugar and Sweets
Vegetables (used for garnish or flavor; with/without sauce: fresh, canned, or frozen; juice, paste, sauces, purees)
Others

Others: Please specify. *

Does your facility process or handle any of the following products? Kindly check all applicable boxes.

Alcoholic Drinks
Drinking Water
Food Additives, Dressings, and Flavorings
Infant Formula
New Dietary Ingredient
Shell Eggs
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF)

Food Packaging

Please check the box(es) that best describe your food packaging products. *

Ceramics
Glass
Metals (ex. tin, aluminum, steel)
Paper and Board
Plastics (ex. polyethylene, polyvinyl chloride)
Printing Inks
Wax
Wood Derivatives (ex. cardboard, paper and paper board)
Others

Others: Please specify. *

Medical Devices

Please check the box(es) that best describe your medical devices. *

Devices for specialized use (e.g., hematology, dental, orthopedic, microbiology, radiologic devices)
Contact lenses
Hearing aids
General hospital and personal use devices (e.g., sterilization indicators, clinical thermometers, bandages, needles, catheters, gloves, applicators, gowns)
Implants
Life-supporting or life-sustaining devices
In vitro diagnostic products
Over-the-counter (OTC) test sample collection systems
Test kits
Others

Others: Please specify. *

Pharmaceuticals

Please check the box(es) that best describe your pharmaceutical products. *

Active pharmaceutical ingredients
Antiperspirant drug products
Compounded drug products
Controlled drugs
Diagnostic radiopharmaceuticals
External drug products
General hospital and personal use devices (e.g., sterilization indicators, clinical thermometers, bandages, needles, catheters, gloves, applicators, gowns)
Human prescription drugs
Human non-prescription and over-the-counter drugs
Skin protectant products
Sunscreen drug products
Tomography drug products
Unfinished drugs
Others

Others: Please specify. *

Tobacco

Please check the box(es) that best describe your tobacco products. *

Cigarettes
Cigars
Dissolvables
Hookah tobacco
Nicotine gels
Pipe tobacco
Roll-your-own tobacco
Smokeless tobacco (dips, snuffs, chewing tobacco)
E-cigarettes, electronic nicotine delivery systems (ENDS), and vapes
Others

Others: Please specify. *

Do you need services? *

Tobacco Tax and Trade Bureau Export Certification (for alcohol products)
Certificate for Cosmetics (for cosmetics subject to section 201(i) of the FD&C Act)
Certificate of Exportability (for conventional foods, food additives, food contact substances, and infant formula products)
Certificate of Free Sale (dietary supplements, medical foods, and foods for special dietary use)
Certificate to a Foreign Government (for conventional foods, food additives, food contact substances, and infant formula)
Certification Services (ex. BRCGS, SQF, FSSC 22000, GMP, HACCP, etc.)
Compliance Services
Consultancy Services (ex. EXIM/Import and Export, FDA/USDA/FSMA, FSVP, GFSI, PCQI, etc.)
FDA-Issued Export Certificates
FDA-Issued Health Certificates (for collagen and gelatin products for export to EU)
FDA-Issued Specified Risk Materials Certificates (for collagen and gelatin products for exported to non-EU countries)
FSVP Qualified Individual (FSVPQI) Services
NOAA Inspection Certificate (for seafood products)
Product Label Regulatory Review
Regulatory Services
U.S. Agent Services
U.S. Market Assistance Services
USDA Grading Certificate (for dairy products)
USDA-Issued Export Certificates
USDA-Issued Certificate (for processed eggs and egg product and composite foods containing egg products)
USDA Specialty Crops Inspection Certificate (for honey products)
No, I am not interested.

Please check all that apply.

Contact Person

We'd like to know further how we can reach out to you.

Point of Contact

First Name *

Email *

Confirm Email

Last Name *

Suffix

ex. Sr., Jr., III, IV

Phone

Country Code *

Phone No. *

Ext.

(if applicable)

Facility Information

Please tell us a bit about the establishment you would like us to register on your behalf.

Layout

Complete Facility Name *

Suffix

ex. "Company", "Corporation", "Incorporated", "Limited", "LLC", etc.

Facility Address

Street Address *

City *

Facility Address (copy)

State/Province *

Country/Area *

Zip Code *

Please make sure to review your entries before clicking the button below. Our team of experts will assess your submission and will invite you for further discussion.