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US FDA Consultants

We are US FDA Consultants for Medical Devices and helping Domestic & Foreign organizations comply with US FDA regulations.

 

We provide quality and regulatory consulting services to drugs, Nutraceuticals, cosmetics, food, medical device organizations regulated by the US FDA. No matter the size and the products manufactured.

US FDA Consultants for Ispection

I3CGLOBAL is considered the leading consulting firm for all FDA compliance in the Asia Pacific and the Middle East region. We were selected among the top 25 ā€œMost Recommended Compliance Service Providersā€ by Perga magazine in the year 2016 & 2017 consecutively.

Our Scope of US FDA Consultants Services

Pre FDA Inspection Support Service

The following are the common type of inspections FDA conduct onsite.

 

  1. Scheduled Pre-approval inspection,
  2. Scheduled Routine inspection,
  3. Scheduled Compliance follow-up inspection, and
  4. ScheduledĀ  / Short Notice ā€œfor causeā€ inspection.

US FDA Audit & FDA 483 response

Notice of Inspectional Observations is officially called FDA form 483. Generally, an FDA 483 is issued by an FDA officer against GMP violation in the Food, Drug, Medical Device or Cosmetic manufacturing or supply chain

 

Those who received a US FDA 483 warning letter either by post or email must respond to FDA in 15 working days. Manufactures must know a nontechnical and poor response will lead to permanent warning and chances of further enforcement action by FDA which may lead to repeated inspection at short notice.

 

A CAPA with through schedule and timeline must be submitted in any case. Here comes the role of an expert consulting company!.

Our Scope of GMP Audit

We can cover up GMP audits based on WHO-GMP, 21 CFR 820, 21 CFR 211, 21 CFR 111

  • Active Pharmaceutical Ingredients ( API ) and intermediates
  • Finished Pharma Formulations
  • Manufacturers of Cosmetics, Medical Devices, Neutraceuticals

I3CGLOBAL team is the “best choice” for clients in the Asia Pacific, Middle East, and Europe. We have the knowledge and experience to support healthcare product manufacturers for handling Warning Letters and/or 483 responses. Our support will be exponentially good for your firm!

Write to us

enquiry@i3cglobal.com

What are the advantages of GMP implementation?

  1. Internal Quality audit of the system.
  2. CAPA
  3. Risk assessment and Risk Mitigation
  4. Preparation tool for regulatory inspection
  5. Training and training effectiveness monitoring
  6. Outsourced vendor controls
  7. Better resource utilization
  8. Better productivity