A TRUSTWORTHY REGULATORY CONSULTING COMPANY AND YOUR SUSTAINABLE PARTNER!
FOR EU, USA & UK REGULATIONS
Discover more about I3CGlobal Company and gain insights into our services and capabilities
At I3CGLOBAL, we believe in honesty, integrity, and fairness in everything we do. Our commitment to these values has earned us the trust and respect of our existing customers, making us recognised as the best in the industry!
What is special with us and how we addressed medical device manufactures challenges!
*** Regulatory documentation and registrations with regulatory authorities may seem simple, but they constitute a highly complex, resource-intensive, and time-consuming task. It is always best to entrust these responsibilities to the regulatory experts.
EXPERIENCED REGULATORY CONSULTANTS
With extra regulatory consulting team manpower always, we stand prepared to initiate any project swiftly. Our team of dedicated full-time regulatory experts ensures a prompt and efficient commencement for all your projects, prioritising on-time delivery.
FAIR PRICE & ONTIME DELIVERY
Our clear and consistent pricing on the I3CGlobal website has attracted customers from around the world. People appreciate our commitment to fairness and reliability, making us a go-to choice for those who value transparent pricing with guarantee of quality.
DATA SECURITY & CLOUD DOCUMENTATION
Certified with ISO 27001 for data security, we go the extra mile to ensure the confidentiality and integrity of your information. Operating around the clock with a 24/7 uptime guarantee, we diligently work, maintain, and securely deliver documents via the cloud, providing you with a reliable and secure regulatory consulting service at all times.
MEDICAL DEVICES (EU)
Technical Documentation
MDR / IVDR Technical File or Documentation is to demonstrate the safety and performance of medical devices.
Clinical Evaluation Report
Clinical Evaluation Report as per MDR article 61 and MEDDEV Rev 4, is a must for Medical Device CE Certification.
CE Marking
We found many startups coming with new Standalone Medical Software's, and all has to undergo CE Marking to distribute in EU.
EU Representative
Non European manufactures must appoint European Authorised Representative by law, for importing and marketing device in Europe.
UK Responsible Person
Non UK or European manufactures must appoint UK Responsible Person (UKRP) for lawfully placing the device in UK market
EU IVDR Regulation
EU 2017/746 In Vitro Diagnostic Regulation (IVDR) is the new and many earlier exempted devices now jumped into high risk
Medical Device (FDA)
FDA 510(k) File
We solve every obstacle in the path of Class I, II, and III Medical Device 510k Premarket Notification by carefully developing the 510k file
510(k) Documentation
We provide cost-effective 510k documentation, US Agent, and FDA coordination services through the entire process until 510k clearance.
510(k) Consulting
If you’re looking for best 510k consulting services, your search is over. We can help you with all of your 510k needs.
Establishment Registration
We offer service for FDA Medical Device Establishment Registration and listing along with UDI submission.
FDA 510(k) Submission
FDA 510k File Documentation, Testing (Inhouse and external) and pre-submission may take up 4-5 months.
The timeline mainly depends on models and variants of the device.
Q Submission allows the 510k applicant to get more in-depth feedback on how and what to be submitted to FDA.
I3CGLOBAL makes all things possible through its comprehensive 510(k) consulting services.
DRUGS
21 CFR 211
21 CFR 211 also know as GMP details minimum requirements for the methods, facilities, and controls used in manufacturing,
Drug Master File
Drug Master File (DMF) is a confidential document voluntarily submitted to FDA by manufacturers of drug packaging materials and producers of drug and allied products.
FDA Drug Establishment Registration Support and Services
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.
FOOD/FOOD SUPPLEMENTS
FDA Food Facility Registration
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 211 Consulting
21 CFR 111 GMP is for those involved in manufacturing, packing, or holding human food supplements.
COSMETICS
US FDA Agent Services
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.
US FDA Certificate
FDA Certificate often provided by agents post facility registration, often used by customers and suppliers to verify their registration number
FDA Cosmetic Registration Services
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.