Medical Device and Drug Regulatory Consulting Services

Quality or compliance?  Why not both? 

Navigating the necessary parameters of compliance while also assuring improvements in business performance, product and service quality can be challenging.  Our goal in working with your organization is to aid you to identify and determine compliance with applicable regulations and standards, evaluate actual adherence to the processes described in your quality system, detect potential quality issues, and to assist you with defining and implementing solutions that address compliance, quality with a clear understanding of business value add.  Typical standards and regulations include:

  • 21 CFR 803
  • 21 CFR 806
  • 21CFR 807
  • 21CFR 820
  • 21CFR 830
  • 21CFR 210
  • 21CFR 211
  • ISO 13485:2016
  • ISO 9001:2015
  • ISO 14971: 2019

I will continue to work with Two Harbors Consulting (as they provided):  verbal and written daily wrap-up very helpful; discussion at each point beneficial to feeling 100% informed; able to truly have a collaborative approach which is what I need in this particular audit; meaningful discussions on various considerations regarding approaches to compliance without compromising your ability to independently review; manner of discovery/questioning helps employees prepare to answer future inspection questions without feeling threatened; solid interpretation and reasonable application expectations of regulations; understanding of general best practices with a quality system.” Michael T, VP of Quality, Medication Repackaging