US FDA CONSULTANTS

Our aim is to equip our clients with the information they need to comply with the FDA’s most recent requirements, allowing them to produce the highest quality pharmaceuticals, food, cosmetics and medical devices available.

KNOW US

As FDA Consultants team I3CGlobal is made up of a powerful combination of compliance, regulatory, scientific, and technical experts who are very good at solving and documenting problems. Working from our offices in Germany, India, Malaysia, the United Kingdom, the United States of America, and Vietnam, we arrive at the customer’s location in the shortest time and at the lowest cost.

FDA DOCUMENTATION CONSULTANT

Hundreds of domestic and foreign manufactures and exporters have used the I3CGlobal team to review and develop documents for FDA approval,  mainly are

  • 24 X 5 Chat support. 50+ Full time employees

  • 6 days working and processing documents

  • Weekly project status and meetings

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information

The process involved in the Drug Master Filling with US FDA.

Step 1: Identification of product and applicable requirements

Step 2: Testing of the product

Step 3: Prepare the Drug Master File

Step 4: Appoint US Agent

Step 5: Electronic conversion of DMF

Step 6: Receive the DMF number

Medical Device Labelling. Read More

Drug Labelling Infomation. Read More

Food Labelling Guide. Read More

Labelling & Nutrition Guidance. Read More 

FDA GMP CONSULTANTS

Hundreds of domestic and foreign manufactures and exporters have used the I3CGlobal team to review and develop documents for FDA approval,  mainly are

  • Performing FDA pre-approval (mock) inspections

  • Serving from different cities across the Globe

  • Execution of numerous remediation and corrective action plans

Food Manufacturing

Neutraceutical manufacturing

Drug manufacturing

Medical Device manufacturing

API manufacturing

FDA CONSULTANTS FOR PROBLEM RESOLUTION

Hundreds of domestic and foreign manufactures and exporters have used the I3CGlobal team to review and develop documents for FDA approval,  mainly are

  • OTC Drugs

  • Active and Non Active Medical Devices

  • Cosmetics and Neutraceuticals

How to respond in case an FDA 483 inspection report issued

How to respond to an FDA Warning Letter

FDA CONSULTANTS FOR FACILITY DESIGN

When manufacturers face facility-related compliance challenges, I3CGlobal Consultants is experienced in providing suitable world-class layout and design covering all regulatory obstacles.

  • Assured approval from leading regulatory agencies

  • Delivery in 3-4 months or may be faster

  • Economic pricing and experienced professionals

Layout Design for Medical Device, Drugs and Neutraceutical Industries.

Area / Land / Site approval for the construction

Area / Land / Site approval for the construction

CONTACT US

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