Quality Systems Consulting Services provides Regulatory Compliance Consulting, Operational Excellence programs, Validation support, Remediation Solutions, and Staff Augmentation to medical device and pharmaceutical companies.
Our goal is to provide you with REVENUE NEUTRAL COMPLIANCE: delivering Regulatory Compliance while identifying and implementing opportunities for effectiveness and efficiency
QUALITY SYSTEM OPPORTUNITIES
The internal and external costs of non-compliance resulting from the Food and Drug Administration regulatory actions or Notified Body findings can be significant. Proactively addressing any non-compliance or quality systems issues BEFORE they become a problem will help your business build brand strength and produce a higher quality product.
of the Curve
Effective and Efficient Compliance Strategies
Three Easy Steps to Solve Your Problem
A QSCS Consultant’s job is to help your company succeed. We have the experience and knowledge to help your business deal with quality and compliance issues that may arise.
The steps to stress-free compliance are:
Call us to discuss your needs.
Together we will develop the strategy to solve your problem
We provide the consultants that will help your company succeed.
Let Your Compliance Solution Pay for Itself
Quality System Consulting Services can help you develop, improve, remediate, and optimize all of your global quality system and regulatory requirements. It is our goal to provide you with REVENUE NEUTRAL compliance.
Top Notch Consultants
for Businesses Large and Small
Our consultants and partners have experience and skills representing a “who’s who” within the Medical Device and Pharmaceutical Industry. They are industry leaders that come from different levels (Vice Presidents, Directors, Managers and Engineers) and from different functions (Quality Assurance, Regulatory Affairs, Research and Development, and Operations). They have worked in small, start-up enterprises up to multi-billion dollar, multi-national organizations.
They have lead or provided guidance in remediating FDA a nd Notified Body enforcement including Consent Decrees, Warning Letters, Recalls, Post-Market Surveillance, MDRs, and problem CAPAs.
Just a few of the companies who have trusted us with the compliance needs: