Pharmaceutical Division

We Know Pharma

The Pharmaceutical Division was created to focus on our roots and provide you with the most qualified auditors & consultants who understand the healthcare industry from their extensive industry experience. We have auditors & consultants who are specifically qualified to support the most demanding Pharmaceutical clients and dedicated support staff focused on the changing regulations and industry challenges so you can focus your resources elsewhere.

We hope you’ll explore the site to see the services we offer. Our team is truly the best in the business and we look forward to hearing from you so we can start the process of working together.

21 CFR 210/211
GCP
GMP

Our Experts Drive Your Competitive Advantage

Our people share perspectives gained from decades of dedicated industry focus and thousands of engagements. They speak your language. They understand your world. Their industry insights provide you with a truly distinctive edge.​
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Global Reach, Local Presence

By having auditors located within driving distance of nearly clients (95%+ to date) – you spend your limited budget on hiring experts, not paying for airfare & hotels. This worldwide presence offers the benefit of rapid deployment and reduced lead-time for audit scheduling.

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Proven Expertise

Our auditors & consultants are recognized as leaders in the pharma industry. They have credentials by industry leading organizations including RAPS, ISPE, SQA, ASQ, & IRCA (and more) and have a broad range of real-world experience, education, and backgrounds. We stay on top of changes from the FDA and other regulators. For our clients, this translates to the best, most up-to-date knowledge of FDA expectations and industry best practices. 

We utilize a proprietary system for qualifying and monitoring performance of our team to ensure that you always receive the highest level of service.

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Guaranteed Satisfaction

We’re so confident in our ability to meet your needs that we offer a 100% satisfaction guarantee. Simply put, if you aren’t happy with the service we provide, give us one chance to make it right. If we can’t get it right the next time – we will refund your money. Plain and simple.

Services

We provide Auditing & Consulting services to leading Pharmaceutical companies worldwide.

Internal Auditing

Supplier Auditing

Training

Compliance Consulting

Internal Auditing

Internal Audits are a universal regulatory requirement across the pharmaceutical industry & supply chain. Some of the top reasons our clients say they contracted us to conduct some of all of their internal audit includes:

  • Internal Resource Constraints: Whether you’ve lost key employees in your Quality Department or your internal staff is working on other priorities, we make it easy to ensure you meet your annual internal audit obligations.
  • Lack of Expertise: Auditing is a very specialized skill and research has found that many small organizations find it more cost effective to outsource their internal audit than expend the time and money to train auditors internally.
  • Insight into Industry Trends: We perform hundreds of audits per year and our auditors are able to advise clients on changes in the regulatory environment and best practices that are otherwise challenging to keep up with.
  • Conflicts of Interest: Many small organizations are unable to conduct internal audits without breaching the requirement that auditors are impartial/independent of the areas that are being audited. In larger organizations, we are sometimes brought in to eliminate potential political challenges that can be distracting in an audit.

Regardless of the reason, Quality Auditing LLC is well equipped to assist you with an internal audit of your QMS. The scope of the audit will be tailored specifically to your needs and requirements.

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Supplier Auditing

Auditing of suppliers to Pharmaceutical industry requirements can be a daunting task. Quality Auditing LLC can conduct on-site supplier audits on your behalf to ensure that the activities you have contracted them for are being executed according to your requirements and applicable cGMP regulations.

Our Supplier Auditing Program helps to provide systematic and constant monitoring of your suppliers to mitigate potential supply chain risk and drive continual improvement activities. The scope of our supplier auditing services ranges from a single audit to the complete management of an entire supplier auditing program, from scheduling the audits, to closure of audit nonconformances. The proximity of our auditors to your suppliers anywhere in the world ensures that these audits can be with executed quickly, with local experts who literally speak the language of your suppliers and know the culture.
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Training and Compliance Consulting

At Quality Auditing, we excel in providing QMS Implementation, Training, and Consulting designed to elevate your organization's performance, mitigate risks, and ensure compliance with stringent regulatory standards. Our primary focus is on offering comprehensive Quality Systems training and consulting specifically crafted for the pharmaceutical sector. We understand the complex landscape of pharmaceutical quality and regulatory requirements, including FDA Regs, IPEC, ICH, WHO guidelines, and more. Our customized training solutions are meticulously designed to equip your team with the knowledge and tools necessary to navigate these regulatory frameworks effectively. Partner with Quality Auditing for unmatched industry expertise, practical insights, and personalized guidance in achieving and maintaining compliance with pharmaceutical quality and regulatory requirements. Let us help you optimize your processes, minimize risk, and achieve excellence in quality management.
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Trusted By

Pace
QuidelInc
SGS
Solvay
Steris
Tekni-Plex
Unilever
Albemarle
Amcor
Aramark
ColeParmerLLC
Dow
Dupont
Eurofins
Fluke
Fresenius_Kabi
GileadSciences
GSK
Intertek
Merck
Mettler Toledo
Millipore Sigma
Oliver

Pharmaceutical auditing best practices customized for you

Throughout our many years working in the pharmaceutical industry, we have created and refined a systematic, phased approach to regulatory compliance auditing based off of ISO 19011:2018 Guidelines for Quality Management Systems Audit and our experience in FDA and other global regulations.

Our goal is ensure consistent delivery of top quality service to ensure we meet and exceed your quality objectives. Experience has shown that successful partnerships require clear and constant communication before, during, and after an audit. The typical process we follow is shown below:

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Want to talk to us directly?
Give us a call!

Please call us at 612-208-7845

The type of information we’ll want to discuss when you call includes:

  • Type of service
  • Location
  • Potential Service Date(s)
  • Any other special needs.

 

If you’re unsure of anything – that’s ok!

Our experts will help talk through the process.

Request a quote by filling out the form below and we will contact you as soon as possible


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Quality Auditing LLC is the Gold Standard of Auditing.

About

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Quality Auditing, LLC

Corporate HQ:
225 South 6th St. Suite 3900
Minneapolis, MN 55402

612-208-7845
support@qualityauditing.com

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