Our Services

At Kim Walker Consulting, we provide our clients support with global regulatory, clinical, and quality system requirements.

We offer guidance and hands-on assistance to optimize the time to market for your products. We provide Total Product Lifecycle regulatory support, regulatory strategy, design control support, clinical trial strategy and design, GCP compliance and audit capabilities, pre-market submissions, quality system audits, and post-marketing support.

Listed below are some examples of the types of services we provide:

Regulatory Pre-Market Submission Strategies
US Pre-market Submissions – PMA, HDE, IDE, EUA, Pre-Sub/Q-Sub, and 510(k)
Global Pre-Market Submissions – European CE Mark Technical Files/Design Dossiers (MDR and IVDR), Canada Medical Device Licence, Japan, Australia, Latin America, etc.
CLIA Waiver Applications and Submissions
Clinical Trial Strategy, Design, and Project Management
GCP Auditing
Quality System Design, Development, and Auditing – including ISO 13485, FDA QSR, MDR/IVDR, MDSAP, Health Canada, Australia TGA, and Japan MHLW requirements
Adverse Event, MDR, and Vigilance Reporting Assistance
Recall and Field Corrective Action Assistance
Risk Management Design, Development, and Auditing – including ISO 14971 compliance
CAPA Design, Development, and Assistance
Import/Export Compliance Review and Assistance
Labeling Compliance Review and Assistance
Establishment Registration and Device Listing Assistance – including FDA and State of CA FDB
FDA Form 483 and Warning Letter Review and Assistance
Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
On-site training available on all the above listed topics
FDA, Notified Body, and Competent Authority liaison and negotiator
Due Diligence Auditing

Regulatory Pre-Market Submission Strategies
Pre-market Submissions – ANDA, OTC Monograph, BLA, IND, and Pre-IND
Clinical Trial Strategy, Design, and Project Management
GCP Auditing
Quality System Design, Development, and Auditing – including ICH and FDA cGMP requirements
Adverse Event and Pharmacovigilance Reporting Assistance
Recall Assistance
Risk Management Design, Development, and Auditing – including ICH Q9 compliance
CAPA Design, Development, and Assistance
Import/Export Compliance Review and Assistance
Labeling Compliance Review and Assistance
FDA Form 483 and Warning Letter Review and Assistance
Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
On-site training available on all the above listed topics
FDA and Competent Authority liaison and negotiator
Due Diligence Auditing

Pre-market Compliance Assessment
Clinical Trial Strategy, Design, and Project Management
GCP Auditing
Quality System Design, Development, and Auditing – including FDA cGMP requirements
Complaint Handling and Adverse Event Reporting Assistance
Recall Assistance
Risk Management Design, Development, and Auditing
CAPA Design, Development, and Assistance
Import/Export Compliance Review and Assistance
Labeling Compliance Review and Assistance
FDA Form 483 and Warning Letter Review and Assistance
Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
On-site training available on all the above listed topics
FDA and Competent Authority liaison and negotiator
Due Diligence Auditing

Regulatory Pre-Market Submission Strategies
US Pre-market Submissions – PMA, HDE, IDE, EUA, Pre-Sub/Q-Sub, and 510(k)
Global Pre-Market Submissions – European CE Mark Technical Files/Design Dossiers (MDR and IVDR), Canada Medical Device Licence, Japan, Australia, Latin America, etc.
CLIA Waiver Applications and Submissions
Clinical Trial Strategy, Design, and Project Management
GCP Auditing
Quality System Design, Development, and Auditing – including ISO 13485, FDA QSR, MDR/IVDR, MDSAP, Health Canada, Australia TGA, and Japan MHLW requirements
Adverse Event, MDR, and Vigilance Reporting Assistance
Recall and Field Corrective Action Assistance
Risk Management Design, Development, and Auditing – including ISO 14971 compliance
CAPA Design, Development, and Assistance
Import/Export Compliance Review and Assistance
Labeling Compliance Review and Assistance
Establishment Registration and Device Listing Assistance – including FDA and State of CA FDB
FDA Form 483 and Warning Letter Review and Assistance
Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
On-site training available on all the above listed topics
FDA, Notified Body, and Competent Authority liaison and negotiator
Due Diligence Auditing

Regulatory Pre-Market Submission Strategies
Pre-market Submissions – ANDA, OTC Monograph, BLA, IND, and Pre-IND
Clinical Trial Strategy, Design, and Project Management
GCP Auditing
Quality System Design, Development, and Auditing – including ICH and FDA cGMP requirements
Adverse Event and Pharmacovigilance Reporting Assistance
Recall Assistance
Risk Management Design, Development, and Auditing – including ICH Q9 compliance
CAPA Design, Development, and Assistance
Import/Export Compliance Review and Assistance
Labeling Compliance Review and Assistance
FDA Form 483 and Warning Letter Review and Assistance
Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
On-site training available on all the above listed topics
FDA and Competent Authority liaison and negotiator
Due Diligence Auditing

Pre-market Compliance Assessment
Clinical Trial Strategy, Design, and Project Management
GCP Auditing
Quality System Design, Development, and Auditing – including FDA cGMP requirements
Complaint Handling and Adverse Event Reporting Assistance
Recall Assistance
Risk Management Design, Development, and Auditing
CAPA Design, Development, and Assistance
Import/Export Compliance Review and Assistance
Labeling Compliance Review and Assistance
FDA Form 483 and Warning Letter Review and Assistance
Conduct assessments of client analytical studies, clinical studies, procedures, and programs to determine regulatory gaps and compliance
On-site training available on all the above listed topics
FDA and Competent Authority liaison and negotiator
Due Diligence Auditing

If you require other regulatory services, please contact us to discuss your needs.

If we are not able to assist you, we are always glad to help you find the subject matter experts you need.

Kim Walker Consulting

At Kim Walker Consulting, we provide our clients support with global regulatory, clinical, and quality system requirements.

Listed below are some examples of the types of services we provide:

If you require other regulatory services, please ﻿contact us ﻿to discuss your needs.

If you require other regulatory services, please contact us to discuss your needs.