I3CGLOBAL insists on honesty, integrity, and fairness in all aspects of our business and expects the same in its relationships with domestic and international customers. This has earned the trust and respect from our existing customers and is acknowledged as the best!
High Quality Regulatory Consultants
Regulatory Documentation and establishment registrations with regulatory bodies - this process seems simple but it is a highly complex, resource-intensive and time-consuming task. It is always best to leave it to the experts at I3CGLOBAL!
What is special with us and Why our customers like us?
Our strong technical team spread in three continents along with their commitments to core values has helped I3CGLOBAL build long-term, value-centric relationships with customers and become one of the best and dependable global US FDA Agent & EU Medical Device Regulatory Consulting Company.
MEDICAL DEVICES (EU)
MDR/IVDR Technical Documentation or Technical File is to demonstrate the safety and performance of medical devices
Clinical Evaluation Report as per MDR article 61 and MEDDEV Rev 4, is a must for Medical Device Technical Documentation and CE Certification
We found many startups coming with new Standalone Medical Software's, and all has to undergo CE Marking to distribute in EU
Non European Device manufactures must appoint European Authorized Representative by law to distribute the product in Europe.
Non UK European manufactures must appoint UK Responsible Person (UKRP) for lawfully placing the device in UK market
EU 2017/746 In Vitro Diagnostic Regulation (IVDR) is the new and many earlier exempted devices now jumped into high risk
Medical Device (FDA)
We solve every obstacle in the path of Class I, II, and III Medical Device 510k Premarket Notification by carefully developing the 510k file
We offer economic service for 510k documentation, guidance, US Agent and FDA coordination activities till 510k clearance.
If you’re looking for best 510k consulting services, your search is over. We can help you with all of your 510k needs.
We offer service for FDA Medical Device Establishment Registartion and listing along with UDI submission.
FDA 510k File documentation, testing (Inhouse and external) and pre-submission may take up almost 4-5 months. The timeline mainly depends on models and variants of the device too.
Pre or Q Submission allows the manufacturer/applicant to get more in-depth feedback on how and what to be submitted to FDA.
All possible with the service offered by I3CGLOBAL
Medical Device Manufacturers Challenges
Here are a few challenges that we have heard from the medical device manufacturers
We have the largest pool of full-time technical consultants. Any project can be started quickly.
Customers across the globe are attracted to us due to our fixed and fair pricing policy.
We are certified for ISO 2711 for data security. We work, we maintain and we deliver documents via the cloud with 24 x 7 uptime assurance.
21 CFR 211 also know as GMP details minimum requirements for the methods, facilities, and controls used in manufacturing,
US FDA DMF is a confidential document submitted voluntarily to the FDA by human drug manufacturers, processors, packagers, and stores
US FDA controls the sale of drugs.
All establishments have to register and list the drug products before the sale or import of such products to the United States of America.
The registration is to be followed by Finished drug manufacturers, brand owners, API manufacturers, and drug testing laboratories.
The USA Bioterrorism Act directs FDA to take steps to protect the public from any threats via the food supply.
To carry out, the FDA enforces all manufacturers and importers to register their facilities involved in the supply chain.
It also imposes us with the requirement to be given advance notice on shipments of imported food also known as prior notice.
21 CFR 111 GMP is for those involved in manufacturing, packing, or holding human food supplements.
FDA Agents are the primary contact point person or company between the foreign facility and the FDA in case of any emergency and routine registration matters.
FDA Certificate often provided by agents post facility registration, often used by customers and suppliers to verify their registration number
The Voluntary Cosmetic Registration Program, so-called VCRP regulation is made by the FDA for cosmetic manufacturers and brand owners.
VCRP insists that all ingredients used for cosmetic products must be intimated to the FDA via a so-called system called ingredient statement filing.