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Kinetic Compliance Solutions

United States

Overview

We deliver flexible, pragmatic and cost-effective legal & regulatory solutions via a modern service model to give you a competitive edge. We partner with you to address your long and short term needs by leveraging our in-depth industry expertise and solutions-oriented mindset. Whether you are looking for "external in-house"? expertise or surge support, we know what it takes to succeed in a fast-paced, cost-conscious business environment and will work with you to provide tailored solutions that meet your needs and budget. Our legal services include general advice and counseling on a broad scope of transactional / commercial matters as well as healthcare (medical device and life sciences) industry expertise. Our regulatory services include creating regulatory strategies, gaining market access (510(k), CE marking and Health Canada licensing), assisting in clinical trial compliance and more. As your business partners, we tailor our services and pricing models to meet your unique needs, including offering alternative fee arrangements where we are willing to share some of the risk.

Areas of subspecialty

483 responses
Warning Letter Responses
Remediation Strategies
Labeling and Website Reviews
Audits and Gap Analyses
Mock FDA Inspections
Regulatory Submissions
Areas of service
  • North America