Kim Walker Consulting
About
Kim Walker Consulting provides tailored regulatory, quality systems, and clinical support for companies navigating global healthcare product requirements. We help clients optimize time to market while maintaining compliance throughout the product lifecycle.
SERVICES PROVIDED
Use Authorizations (EUA), 510(k) Submissions, De Novo Applications, PMA, HDE, CLIA Waivers, IDE, IND, Pre-IND, BLA, ANDA, CE Mark Technical Documentation, Health Canada Submissions, and other global regulatory submissions.
QUALITY SYSTEMS
GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, and Pre-Approval Inspection (PAI) audits.
CLINICAL AFFAIRS
Clinical trial design, protocol development, investigator brochures, clinical management procedures, GCP audits, IND and IDE preparation, and clinical data support for regulatory submissions.
POST-MARKET SUPPORT
Labeling reviews, complaint handling systems, MDR and vigilance reporting, risk management, CAPA support, import/export assistance, establishment registration, device listing, FDA Form 483 responses, and warning letter review and remediation.
TRAINING
On-site and customized training programs are available for all of the services listed above.
Contact
REGULATORY AFFAIRS
513(g) Requests, Q-Submissions (Q-Sub), Emergency Use Authorizations (EUA), 510(k) Submissions, De Novo Applications, PMA, HDE, CLIA Waivers, IDE, IND, Pre-IND, BLA, ANDA, CE Mark Technical Documentation, Health Canada Submissions, and other global regulatory submissions.
QUALITY SYSTEMS
GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, and Pre-Approval Inspection (PAI) audits.
CLINICAL AFFAIRS
Clinical trial design, protocol development, investigator brochures, clinical management procedures, GCP audits, IND and IDE preparation, and clinical data support for regulatory submissions.
POST-MARKET SUPPORT
Labeling reviews, complaint handling systems, MDR and vigilance reporting, risk management, CAPA support, import/export assistance, establishment registration, device listing, FDA Form 483 responses, and warning letter review and remediation.
TRAINING
On-site and customized training programs are available for all of the services listed above.