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(800) 960-1080
info@kslbiomedical.com
 
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Consulting

 

Regulatory/Quality Support for Healthcare Businesses

 

Compliance Project Management

 

KSL Biomedical was established by professionals with decades of experience in US and international regulatory compliance, product design and development, clinical trials, and protection of intellectual property to work with health care industry partners to address their need for special resources to achieve and maintain compliance. Team members have worked with all levels of compliance: state, national and international inspectors, regulatory authorities and quality registrars in the laboratory service, medical device, IVD, pharma, food and supplement fields. 

 

KSL is positioned to support companies contemplating commercial launch into new markets or responding to new regulatory requirements. This applies equally well to start-ups looking to build out a new Quality Management System (QMS) or established companies looking for interim support on new projects or to identify Regulatory / Quality professionals with a specific expertise. 

 

We know the challenges companies face launching products in new markets and can help accelerate access. Our staff has managed approval of thousands of products in the United States, Canada and Mexico through FDA listing, 510k clearance, PMA, Health Canada licensing, State Department of Health validations, etc. We have similar experience with CE mark in the EU and registration, licensing and distribution in difficult markets like China. 

Regulatory / Quality Consulting

International regulatory support for bioscience, medical device, IVD and aligned companies

  • Quality management systems (QMS) — ISO/GMP/GLP/FDA QSR QMS design and implementation; Gap analysis; Compliance audits

  • North America Licensing — US FDA / Health Canada establishment licenses; Device / Product registration and listing; State laboratory licenses; In-country representation

  • Clearance and approvals — Regulatory strategy for market entry; 510k / PMA submission; Lab Developed Test (LDT) approvals; CE Mark

  • FDA Inspection consultation and on-site support

Contact our professionals now to help your company grow worldwide.

Clinical Studies

Clinical planning, laboratory testing, and medical advisor consultation

  • Pre-clinical strategy, clinical evaluation reports and post market studies

  • Pre-clinical/Clinical study testing and support

  • Medical advisor review and risk consulting​

Contact our professionals now to help your company grow worldwide.

Chinese-English Translation

QMS, regulatory and technical content translation services

  • QMS documents: policies, procedures, SOPs

  • Design files

  • Technical reports

  • Regulation submissions (e.g. 510k filings and responses)

  • On-site translation support for international audits

Contact our professionals now to help your company grow worldwide.

Translational Medicine Consulting

Managing health care technology from inception to launch

  • Design and development of proprietary biomedical intellectual property (IP)

  • Technical consulting

  • Production process design

  • International IP review

  • North America patent submissions.

Contact our professionals now to help your company grow worldwide.