(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
Hand Sanitizers
Excellent Rated on Trustpilot and Google
15 years of experience
No Hidden Fee
Transparent Pricing
Quick Response
Example DMF Drug Master File
2
Nov
2016
BACK
other services
Drugs
Medical Device
Food
Cosmetic
Recent Post
FDA fee for OTC drugs – OTC monograph Drug User fee
FDA Registration Renewal timelines – when to renew your FDA registration.
How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer
FDA establishment registration fee FY 2021
Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020
FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products
Archive
January 2021
September 2020
August 2020
April 2020
March 2020
October 2019
September 2019
August 2019
June 2019
April 2019
March 2019
February 2019
January 2019
September 2018
November 2017
May 2017
April 2017
March 2017
February 2017
November 2016
tags
Translate »