Kim Walker Consulting
At Kim Walker Consulting (www.kimwalkerconsulting.com), we provide our clients tailor-made support with global regulatory, quality system, and clinical requirements. We offer guidance and know-how to optimize the time to market for your products. We provide Total Product Lifecycle regulatory support, design control support, clinical trial design, GCP compliance and audit capabilities, pre-market submissions, quality system audits, and post-marketing support. The types of products we work with include:
- Medical Devices
- Combination Products
- OTC Pharmaceuticals
- Dietary Supplements
Pre-Market Submission services include creating and negotiating 513(g), Q-Sub, EUA, 510(k), De Novo, PMA, HDE, CLIA, IDE, IND, Pre-IND, BLA, ANDA, CE Mark Technical File, Health Canada, and various other global regulatory submissions.
Quality System auditing services include GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, and PAI audits.
Clinical Trial services include creating protocols, investigator brochures, clinical management procedures, conducting GCP audits, writing and negotiating IND/IDEs, and writing and negotiating various pre-market submissions containing clinical data.
Post-Market services include labeling reviews, complaint handling support, MDR/vigilance reporting, risk management support, CAPA support, import/export assistance, establishment registration, device listing, FDA Form 483, and warning letter review and assistance.
On-site training is available on all of the above listed topics.