US FDA CONSULTANTS [FDA REGISTRATION CONSULTANTS]
We aim 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 an FDA Consultants team, REGHELPS 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 manufacturers and exporters have used the REGHELPS 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
FDA CONSULTANTS FOR GMP IMPLEMENTATION
Hundreds of domestic and foreign manufacturers and exporters have used the REGHELPS 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/FDA REGISTRATION CONSULTANTS FOR PROBLEM RESOLUTION
Hundreds of domestic and foreign manufacturers and exporters have used the REGHELPS 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
US FDA CONSULTANTS FOR FACILITY DESIGN
When manufacturers face facility-related compliance challenges, I3CGlobal’s FDA 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