(716) 775-0533
Home
About Us
Services
US FDA Agent Services for Foreign Companies
FDA US AGENT
DRUGS
US Agent Services for Drug Companies
US FDA Drug Establishment Registration Services & Renewal Process
IND and NDA filing assistance
Generic Drug Application – ANDA Submission Process
FDA Drug Listing & NDC Number Registration Services
NO CHANGES CERTIFICATION OF PRODUCT LISTING
ECTD Publishing Services
FDA DMF Filing in eCTD format and US Agent
GDUFA SELF IDENTIFICATION
MEDICAL DEVICE
Medical Device Establishment Registration And Device Listing
US Agent for Medical Device Registration
Pre Market Notification
Premarket Approval
Humanitarian Device Exemption
Investigational Device Exemption
De Novo Submission
Food/Dietary Supplement
US Agent services for foreign food companies
FDA Food Facility Registration
Labeling Review
FSVP
FDA Food Labeling Requirements
Establishment registration & process filing
Prior Notice
COSMETICS
Services For Cosmetic Companies
Cosmetic Labeling Requirements Fda
FAQ
US Agent
Drugs
ANDA
DRUG MASTER FILE
Drug ESTABLISHMENT REGISTRATION
OTC Drugs
NDC AND DRUG LISTING
GDUFA SELF INDENTIFICATION
eCTD Requirements and cost effective solutions
Medical device
Food
FSVP – Foreign Supplier Verification
Cosmetics
General
Forms
Drug Listing form
Drug Establishment Registration From
GDUFA Self Identification Form
Medical Device Registration Form
U.S Agent Appointment Form
Food Facility Registration Form
For Facilities Located in the USA
Foreign Food Facility Registration Form
Contact Us
Blog
Services to Ease FDA Regulatory Compliance
contact us
FDAbasics, 15815 SW 11th Court Rd, Ocala, Florida 34473
(716) 775-0533 | (352) 248-0920
Translate »
