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# IQS Consulting

Embed Quality Into Everyday Work

## Sitemaps

- [XML Sitemap](https://intrinsicqs.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Pages

- [Home](https://intrinsicqs.com/) - Committed to helping life science companies maximize cGMP compliance throughout the product lifecycle and reducing risk Our Services CMC and cGMP Assessment for Combination Products Learn More Training andMentoring Learn More Industry Sectors Biopharmaceutical Generic Drugs Combination Products API/ Excipient Follow IQS Consulting
- [IQS Training](https://intrinsicqs.com/iqs-training/) - IQS Training Each of these programs is delivered in an interactive format to engage the participants and ensure knowledge transfer and greater confidence with each topic. Contact us to learn more and obtain a course outline.Pharmaceutical GMP Internal and Corporate Auditor TrainingAuditing the pharmaceutical quality system (PQS) whether for drug products, biologics or combination products
- [CDMO Support](https://intrinsicqs.com/cdmo-support/) - CDMO Support Contract Development and Manufacturing Organizations (CDMOs) are often integral to the success of a pharmaceutical development program and market supply strategy. The maturity of a CDMO’s quality systems, including supplier management, change control, and investigations handling, can mean the difference between program success or program failure. We proactively work with CDMOs to enable
- [Established Company Support](https://intrinsicqs.com/established-company-support/) - Established Company Support With decades of operating experience across multiple geographies and cultures, our consultants provide a hands-on approach to solving problems for established companies. In many cases, well-established companies will handle their needs internally. However, IQS consultants offer tremendous value in the form of an unbiased perspective, subject matter expertise, and an unparalleled desire
- [Development Stage Company Support](https://intrinsicqs.com/development-stage-company-support/) - Development Stage Company Support There is nothing more rewarding than bringing new therapies to patients. The IQS Consulting team of cGMP, Quality System, and CMC experts will assist your team on this journey. Whether your need involves Quality System alignment, auditing your key suppliers, selecting and working with your CDMOs, determining if your team is
- [eQMS Support](https://intrinsicqs.com/eqms-support/) - eQMS Support Support across the eQMS lifecycle Your Quality Management System (QMS) procedures and workflows will reflect the maturity of your Pharmaceutical Quality System. We are often assisting companies raise the level and maturity of their QMS. More frequently we are tasked with supporting the transition to a digitally-based QMS or eQMS. Our objective for
- [Why Intrinsic Quality Systems?](https://intrinsicqs.com/why-intrinsic-quality-systems/) - Why Intrinsic Quality Systems? IQS Consulting is focused on offering consulting services to regulated life science companies to maximize cGMP compliance and reduce risk to patients and to the business.The name Intrinsic Quality Systems (d.b.a IQS Consulting) was chosen to prioritize solutions which embed Quality Systems in routine operations.Our goal is to help your company
- [IQS Consultant Code of Conduct](https://intrinsicqs.com/iqs-consultant-code-of-conduct/) - IQS Consultant Code of Conduct Listen - aim to first understand the client’s objectives, concerns and issues applicable to the assignmentBig Picture - Understand the client’s issues in the context of their products, portfolio, and operating model.Delivery - Work to deliver a high-quality work product which will meet the scope of the work requested by
- [IQS Team](https://intrinsicqs.com/iqs-team/) - IQS Team The IQS Consulting team skill set is derived from years managing quality organizations, pharmaceutical plant operations, and execution of improvement projects. Our experts frequently live and work internationally, bridging technical, regulatory and cultural differences among regions. Jim MorrisFounder and Principal ConsultantBA Biological Sciences, MBA/MA Industrial Organization Brief bio:Jim has been involved in plant operations
- [Core Services](https://intrinsicqs.com/core-services/) - Core Services General Services Quality Management System (QMS) Installation or Remediation We have seen nearly every flavor of a Quality Management System, and a wide variety of workflows for change control, deviations, complaints, etc. Projects often involve the reengineering of an existing QMS or targeted improvement of QMS elements such as Change Control and CAPA.
- [IQS Training Test](https://intrinsicqs.com/iqs-training-test/) - IQS Training Each of these programs is delivered in an interactive format to engage the participants and ensure knowledge transfer and greater confidence with each topic. Contact us to learn more and obtain a course outline. Pharmaceutical cGMP Internal and Corporate Auditor Training Supply chain reliability is a basic business tenet. Supply chain assurance ensures
- [Core Services Test](https://intrinsicqs.com/core-services-test/) - Core ServicesGeneral Services Quality Management System (QMS) Installation or Remediation We have seen nearly every flavor of a Quality Management System, and a wide variety of workflows for change control, deviations, complaints, etc. Projects often involve the reengineering of an existing QMS or targeted improvement of QMS elements such as Change Control and CAPA. The
- [IQS Team TEST](https://intrinsicqs.com/iqs-team-test/) - IQS Team The IQS Consulting team skill set is derived from years managing quality organizations, pharmaceutical plant operations, and execution of improvement projects. Our experts frequently live and work internationally, bridging technical, regulatory and cultural differences among regions. Jim MorrisFounder — Principal Advisor and ConsultantBA Biological Sciences, MBA/MA Industrial Organization Brief bio: Jim has been involved
- [Contact Us](https://intrinsicqs.com/contact-us/) - Contact IQS Consulting For inquiries please send an email to info@intrinsicqs.com
- [Best in Class CAPA and Investigations Systems](https://intrinsicqs.com/best-in-class-capa-and-investigations-systems/) - Best in Class CAPA and Investigations Systems One of the most common issues identified during FDA inspections is failure to investigate discrepancies and inadequate investigations. We work with clients to install a best-in-class program to minimize the risk of regulatory observations in this area. While there is no “one size fits all” approach, there are
- [Quality Management System (QMS) Installation or Remediation](https://intrinsicqs.com/quality-management-system-qms-installation-or-remediation/) - Quality Management System (QMS) Installation or Remediation We have seen nearly every flavor of Quality Management Systems, and a wide variety of workflows for change control, deviations, complaints, etc. Projects often involve the reengineering of an existing QMS or targeted improvement of QMS elements such as Change Control and CAPA. The benefits of QMS include:
- [Continuous Quality System Assurance (CQSA)](https://intrinsicqs.com/continuous-quality-system-assurance-cqsa/) - Continuous Quality System Assurance (CQSA) An expectation of the FDA during site inspection (Pre-Approval Inspection or routine cGMP inspection) is evidence of a mature Pharmaceutical Quality System (PQS). During the inspection, FDA investigators will evaluate the processes for continual quality system improvement. The CQSA framework will provide a company with ongoing feedback concerning the health
- [Best in Class Deviation / Investigation System Improvement](https://intrinsicqs.com/best-in-class-deviation-investigation-system-improvement/) - Best in Class Deviation / Investigation System Improvement A best-in-class investigation system will reduce the level of event reoccurrence, tackle human performance related events, and give confidence to auditors and regulators that the right decisions are being taken regarding batch disposition and CAPA. An evaluation of your system’s metrics, example reports, and the system’s maturity
- [GMP Audit and Assessment](https://intrinsicqs.com/gmp-audit-and-assessment/) - cGMP Audit and Assessment IQS Consulting can support your audit needs by conducting cGMP audits of your API, component and excipient suppliers, cGMP audits of contract manufacturing and testing organizations, or site regulatory inspection preparation assessments and mock audits. New approach: An effective auditor will apply the right guidelines or standards to evaluate an operation
- [cGMP Compliance and Risk Reduction](https://intrinsicqs.com/cgmp-compliance-and-risk-reduction/) - cGMP Compliance and Risk Reduction Maximizing cGMP compliance is not easy; however, one can at least reference relevant requirements and guidelines e.g. 21 CFR Part 210-211, Eudralex Volume 4, etc. Quite often, the interpretation of these rules and guidelines will result in variation in their application.Minimizing risk can be much more difficult due to the
- [CMC and cGMP Assessment for Combination Products](https://intrinsicqs.com/cmc-and-cgmp-assessment-for-combination-products/) - CMC and cGMP Assessment for Combination Products Combination products (drug-device, biologic-device, drug-biologic) are inherently complex and the regulatory pathway to product approval can be challenging to navigate.IQS Consulting will help you understand the GMP requirements for combination products and assist with CDMO selection and provide CMC support. Our focus is ensuring 21 CFR Part 4 requirements
- [Combination Product GMPs and CMC](https://intrinsicqs.com/combination-product-gmps-and-cmc/) - Combination Product cGMPs and CMC Support Combination products (drug-device, biologic-device, drug-biologic) are inherently complex and the regulatory pathway to product approval can be challenging to navigate. IQS Consulting will help you understand the GMP requirements for combination products and assist with CDMO selection and provide CMC support. Our focus is ensuring 21 CFR Part 4
- [Mission Statement](https://intrinsicqs.com/mission-statement/) - IQS Mission “The mission of IQS Consulting is to help companies accelerate product development, reduce variability and ensure patient safety”

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