I 3 CONSULTING, leading Global Quality Assurance & Regulatory Consultants & In-Country Representatives (EU & FDA) to healthcare industries to comply with European and US FDA requirements.
Our network of 100+ management and pharma consultants, 10+ testing laboratories, 36+ full time technical consultants, 4+ office locations in different countries and well-wishers from 3600 + satisfied customers makes us one of the most reputed and trusted service provider delivering economic, quality, time bound, solutions to the customers across the globe.
The overall objective of the EU MDR implementation has been to ensure high level of protection of human health and safety.Classification of Medical Device
How the Medical Device are classified as per new MDR? What are the different class of Medical Devices?Technical File
The Technical File to be prepared for the Medical Device you are planning for CE Mark. It contains all the information relevant toNotified Body
Why notified Body is required for CE Certification? How can we contact them and what is the fees ? How can we contact them?CE Mark Consultants
What is the role of consultant? How they can help you with the CE Certification process. What will be the cost? How consultants selected?Medical Device Export to USA
US FDA Registration and product listing is mandatory. How and what time theClinical Evaluation ( MDR / MEDDEV)
MDR 2017/745, Article 61 and MEDDEV 2.7/1 Rev. 4 Clinical Evaluation and supporting evidences along with report is mandatory for NB.
All medical products applying for CE Certification has to test the medical device as per Harmonized standards. How and where the test to be conducted? What are the test to be?Software CE Marking
Software system that has been developed for the purpose of being incorporated into a Medical Device needs CE LogoISO 13485:2016
Why Implement ISO 13485 for CE Certification process? How can we implement ISO 13485? How long it will take and what will be the cost?European (EU) Authorized Representative
An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. It is required for all non european countries.US FDA 510k
510(k) is a submission made to USFDA to demonstrate that the Medical Device to be marketed is safe and effective as others of similar intended use21 CFR 820
This is a QMS / GMP requirement and to be implement by all the manufactures based on the product category. How long the process and what will be the cost
Good Manufacturing Practice (GMP) applicable for all healthcare manufactures. What are the requirements? How a consultant can help?US FDA Drug Establishment Registration
Those interested to market Finished Formulations, API, Homeopathic Drug, Laboratory Service, should register with US FDA,s Centre for Drug Evaluation and Research.National Drug Code (NDC Number)
National Drug Code is a ten digit unique product identifier number for human drugs. How to get the numberUS FDA Drug Listing
Listing to be done for all drugs planned to sell / Distribute in the United States of America. What is the procedure? How much to cost?US Agent Service
US FDA enforces the need for foreign-based Food, Drug and Medical Device companies without a location in the United States to register with the FDA after appointing a "U S Agent". How can we contact a US Agent? How much it will cost?
A Drug master File is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs.US DMF Submission Fees
Two activities involved are DMF preparation and US Agent Service. We can provide both services for all wishing to have DMF number from FDA.FDA Drug Label Review
It is the responsibility for the drug manufactures to remain current with the legal requirements for prescription and non-prescription or over-the-counter (OTC) drugsEstablishment Registration & Listing Fees
We are US Agents and consultants provide economic service. Checkout our pricingCosmetic Facility Registration(VCRP)
The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US.
Federal Food, Drug, and Cosmetic Act (FD&C act) and the fair Packaging and Labelling insists manufactures and importers toFood Establishment Registration Form
All food and nutraceutical exporters has to register with US FDA. Our consulting service helps to comply with FDA bioterrorism act requirements by?USFDA Food Establishment Registration
(a) Food Manufactures,(b) Food Manufactures & Exporters,(c) Food Exporters and (d) Exporters with Warehouse MUST compulsory register FDAFood Facility Registration Fees
We offer complete solution for US FDA registration with US Agent service. Low Fees.FDA QSR 21 CFR 110 / 111 Requirements
Code of Federal Regulations 21 CFR Part 110 requirements for Current good manufacturing practices (GMPs) for food manufactures
FDA approval depends on the type of product planning to market in the United States.The approvals are limited to scope of products.Food Additives
A food additive is any substance added to food. directly or indirectly to becoming a component affecting the characteristics of any foodFDA Certificate
Manufactures, Exporters and Traders across the globe are curious to have an FDA CERTIFICATE in the name of the company. But this is not possible. US FDA will not issue any kind of FDA Certificate to any kind of organizationUS FDA Food Contact Substance (FCS)
Manufacturers can issue a compliance certificate in compliance with Section 303 c (2) of the Federal Food and Drug Cosmetic act. This section clearly states that penalties are laid down by violation to the act.