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US FDA Consultants

We are US FDA consultants and regulatory professionals who specialize in navigating the complex regulatory requirements set forth by the United States Food and Drug Administration (FDA). Our team of experts provide valuable guidance to establishments in the manufacturing of Food, Food supplements, Medical Devices, cosmetics and OTC pharma products to comply with GMP FDA regulations. Additionally, we help companies develop and implement strategies to address any issues identified during FDA inspections or audits. Overall, US FDA consultants play a crucial role in ensuring that GMP compliance meets the FDA’s rigorous standards for safety, efficacy, and quality.

Scope of US FDA Consultants

The scope of US FDA consultants can vary depending on their expertise and the specific needs of the client.

GMP Certification or GMP Implementation (MDSAP/21 CFR 820, 21 CFR 111, 21 CFR 211, etc.). Consultants can assist in developing and implementing quality management systems to ensure products meet FDA standards for safety, efficacy, and quality.
FDA Pre-Inspection/Mock Inspection.
Consultants can help prepare for and manage FDA inspections and audits, ensuring compliance with FDA requirements and addressing any findings or observations
Product Labeling GAP Assessment and Guidance
483 responses
Warning Letter responses
FDA DMF Preparation & Submissions
FDA 510k Preparation & Submission
FDA Consultants can help classify products according to FDA regulations, which can determine the level of regulatory oversight required.

Overall, the scope of US FDA consultants’ services is broad and can be tailored to meet the specific needs of their clients in navigating the complex regulatory landscape of the FDA.

Pre FDA Inspection Support Service

Preparing for an FDA inspection is a big task for small and medium-sized companies, especially for companies new to the regulatory landscape or those with limited resources. That’s where our Pre-FDA Inspection Support Service comes in.

Scheduled Pre-approval inspection,
Scheduled Routine inspection,
Scheduled Compliance follow-up inspection, and
Scheduled / Short Notice “for cause” inspection.

US FDA Audit & FDA 483 response

The Notice of Inspectional Observations, officially known as FDA Form 483, is typically issued by an FDA officer in response to a violation of Good Manufacturing Practices (GMP) in the food, drug, medical device, or cosmetic manufacturing or supply chain after the scheduled onsite audit. Recipients of a US FDA 483 warning letter, whether by post or email, are required to respond to the FDA within 15 working days. Manufacturers must understand that a non-technical or poorly constructed response may result in a permanent warning and increased chances of further enforcement action by the FDA, including repeated inspections at short notice.

In any case, a Corrective and Preventive Action (CAPA) plan with a detailed schedule and timeline must be submitted. This is where the expertise of US FDA Consultants becomes invaluable. They can help ensure that the response is comprehensive, technically sound, and meets the FDA’s expectations. This can greatly reduce the risk of further enforcement actions and help manufacturers maintain compliance with FDA regulations. I3CGlobal team of experts help manufacturers respond to FDA.

The 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 in handling warning letters and/or 483 responses. Our support will be exponentially good for your firm!

FREQUENTLY ASKED QUESTIONS

enquiry@i3cglobal.com

Do you perform mock FDA inspections?

Yes, we offer mock FDA inspections as part of our consulting services. These simulations provide valuable insights into your organization’s readiness for an actual FDA inspection, helping identify areas for improvement and ensuring compliance with regulatory requirements. Our mock FDA inspections are designed to identify the GAPS, enabling proactive resolution of any potential issues before the FDA team arrives.

Do you support in 483 response?

Yes, we provide support in responding to FDA Form 483 observations. Our experienced team offers guidance and assistance in addressing the findings outlined in form 483, helping your organization develop comprehensive and effective responses to ensure regulatory compliance and resolve any issues identified during the inspection process. Our team ensures that responses are thorough, accurate, and compliant with US FDA regulations, No matter if it medical device, food, drug, API or cosmetics.

Do you support in addressing Warning Letter?

Yes, we provide support in addressing FDA warning letters. Our team offers comprehensive assistance and guidance in developing appropriate responses to the concerns raised in the FDA Warning Letter. We work closely with your organization to formulate robust corrective action plans / CAPA, to ensure compliance with regulatory requirements to resolve the issues outlined in the warning letter effectively.

Do you support in Facility Design in Compliance with US FDA?

Yes, we provide support in designing facilities to ensure compliance with US FDA regulations LIMITED to medical and Invitro diagnostic devices, food supplements, pharmaceuticals, cosmetics etc. Our expertise includes advising on facility layout, equipment placement, workflow optimization, and environmental controls to meet the requirements outlined by the FDA. We collaborate with your team to develop facility designs that promote efficient operations, and lean manufacturing while adhering to relevant FDA guidelines and standards. Additionally, we offer assistance in navigating regulatory requirements to ensure that your facility design meets all necessary compliance criteria, including your product specifications.

What are the advantages of GMP implementation?

Internal Quality audit of the system.
CAPA
Risk assessment and Risk Mitigation
Preparation tool for regulatory inspection
Training and training effectiveness monitoring
Outsourced vendor controls
Better resource utilization
Better productivity