QMS4 provides comprehensive consulting services for commercial organizations, local operating companies (LOC), manufacturing, CMO (Contract Manufacturing Organization), and suppliers. Our services include QMS gap analysis, CAPA (Corrective and Preventive Actions) development and implementation, SOP/Quality System updates, training, and post-implementation reviews until the system is fully operational. We also offer remediation and tailored training services to meet your business needs. For more information, please see our Services, Specialities, Training, and Projects sections.
We primarily serve the Food, Pharmaceutical, API, and Medical Device industries, but our solutions cater to businesses of all sizes. We support organizations seeking certification for ISO 9001, ISO 22000, HACCP, or GMP, as well as those looking to comply with GMP requirements for operations in regulated and non-regulated countries. Our specialty lies in assisting small and medium enterprises (SMEs) and helping large organizations challenge and enhance their systems for long-term sustainability.
QMS4 provides services for a comprehensive range of international standards, including ISO 9001 (Quality Management Systems), ISO 22000 (Food Safety Management Systems), HACCP (Hazard Analysis and Critical Control Points), and various Good Manufacturing Practices (GMP) standards. We assist organizations in complying with critical regulated GMP standards, such as:
- EU GMP
- US FDA GMP (21 CFR Parts 210, 211)
- Australian TGA GMP
- Canadian GMP
- Japanese PMDA GMP
- Swissmedic GMP
- PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme)
For Active Pharmaceutical Ingredients (API), we ensure compliance with ICH Q7 (“Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”). In the pharmaceutical sector, we adhere to other ICH guidelines, such as ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System).
In the food industry, we provide compliance support for ISO 22000, HACCP, and applicable food safety regulations. For companies operating in the U.S., we assist in meeting 21 CFR Part 117 (Current Good Manufacturing Practice for Food).
Additionally, we support compliance with World Health Organization (WHO GMP) guidelines and tailor solutions for businesses that need to meet both local and global regulatory standards in regulated and non-regulated markets.
QMS4 offers tailored, end-to-end solutions starting from gap analysis of existing systems and processes. We challenge your current systems from a third-party perspective and implement improvements, followed by post-implementation reviews (PIR) until all gaps are closed. We also provide After Action Reviews (AAR) and offer regular auditing services to ensure ongoing audit readiness. Our services incorporate the latest in digital transformation, Industry 4.0, and AI technologies, with a focus on practical, cost-effective approaches that ensure compliance and operational excellence.
We assist clients with regulatory compliance by preparing them for audits and inspections, developing SOPs, and aligning their operations with ISO 9001, ISO 22000, HACCP, and GMP standards. We also help companies ensure compliance with parent company standards, particularly for toll or contract manufacturers. Our services are customized to fit each industry’s specific regulatory needs.
QMS4 provides comprehensive support for implementing Quality Management Systems (QMS) in manufacturing operations through a structured approach. We start with a thorough gap analysis to assess your current systems against industry standards and regulatory requirements.
Our services include developing and implementing tailored SOPs, CAPA processes, and training programs specifically designed for your manufacturing environment. We work closely with your team to ensure that all procedures align with best practices and compliance standards, such as ISO 9001, ISO 22000, and GMP.
Additionally, we facilitate continuous improvement by conducting regular audits and post-implementation reviews (PIR) to identify areas for enhancement. This ongoing support ensures that your QMS remains effective, compliant, and capable of adapting to evolving industry challenges.
QMS4 offers tailored support for Local Operating Companies (LOC) and Commercial Organizations by providing a comprehensive approach to Quality Management System (QMS) implementation. We begin with an in-depth gap analysis to evaluate your current quality systems against relevant standards and regulations.
Our services include developing and implementing customized SOPs, CAPA processes, and training programs specifically designed to meet the unique needs of your commercial operations. We collaborate closely with your team to ensure alignment with industry standards such as ISO 9001, ISO 22000, and relevant GMP regulations.
Furthermore, we provide ongoing support through regular audits, monitoring, and post-implementation reviews (PIR) to identify opportunities for continuous improvement. This structured support ensures that your QMS remains effective, compliant, and responsive to market changes and regulatory requirements.
QMS4 offers comprehensive Supplier Development services, ensuring your suppliers meet regulatory and quality standards. Our support includes:
- Conducting due diligence and supplier qualification
- Performing supplier risk assessments to mitigate potential quality issues
- Conducting supplier audits to verify compliance with GMP, ISO, and other international standards
- Developing and implementing Corrective and Preventive Actions (CAPA) for supplier-related issues
- Providing supplier training to improve regulatory compliance, quality performance, and operational efficiency
- Assisting with SOP development, aligning supplier processes with your internal quality systems
- Conducting post-implementation reviews (PIR) to ensure sustained supplier performance
QMS4 provides end-to-end support for Contract Manufacturing Organizations (CMOs) to ensure that their processes align with your quality and regulatory requirements. Our services include:
- Conducting due diligence and CMO qualification
- Performing risk assessments and audits to ensure CMO compliance with GMP, ISO, and other international standards
- Developing quality agreements between your company and the CMO
- Offering third-party audits and CAPA management to resolve issues
- Assisting with SOP development, ensuring the CMO’s processes are aligned with your quality systems
- Providing training to CMOs to enhance quality and compliance
- Ongoing post-implementation reviews (PIR) to monitor and maintain CMO performance
Yes, QMS4 offers both face-to-face and online virtual training options. These can be delivered as group sessions or customized for individual organizations, ensuring that training meets the specific needs of your business. For more information, see our Training Services section.
Yes, QMS4 offers comprehensive New Product Introduction (NPI) services, supporting businesses from the development phase through to product launch. Our NPI services include quality planning, regulatory compliance, product development support, risk management, SOP development, supplier qualification, manufacturing process validation, and post-launch reviews. We ensure that your product meets all applicable regulatory requirements, including GMP and ISO standards, and is launched successfully while maintaining the highest levels of quality and efficiency.
Third-party consultants like QMS4 provide objective, expert insights that help identify process gaps while avoiding internal conflicts of interest, particularly in areas such as staff training, internal audits, supplier audits, contractor audits (CMOs), and investigations, including root cause analysis (RCA) conducted by your internal team. Internal teams often face challenges balancing their existing roles and responsibilities with tasks like training, auditing, QMS gap analysis, due diligence, RCA, CAPA implementation, and verification, which can lead to suboptimal outcomes.
By using QMS4, you ensure that training, gap analysis, auditing, RCA, CAPA, and post-implementation reviews (PIR) are conducted thoroughly by an independent third party. This approach minimizes repeated errors, helps you meet internal and regulatory standards, and alleviates work pressure and conflicts of interest. Our specialized expertise and resources streamline the process, ensuring effective implementation and continuous improvement.
Confidentiality is fundamental to our work. We follow strict protocols to safeguard client information and always work under non-disclosure agreements (NDAs). Your sensitive data is handled with the utmost professionalism and security.
Yes, top management sponsorship is essential for the successful implementation of a QMS. Their commitment ensures the necessary resources are available, helping align the QMS with organizational goals for optimal results.
Organizations of all sizes in the Food, Pharmaceutical, API, Medical Device, and related industries can benefit from QMS4’s consulting services. We assist companies in building, enhancing, or challenging their Quality Management Systems to achieve continuous improvement and regulatory compliance.
We understand the specific challenges that SMEs face in implementing and maintaining QMS. QMS4 offers practical, scalable, and cost-effective solutions tailored to smaller organizations. Our flexible approach helps SMEs achieve compliance and operational excellence efficiently.
You can contact us via our website or WhatsApp to arrange an initial consultation. During this consultation, we will assess your needs and tailor a solution for your business. For more details, please check out our Service Model.
As part of our introductory offer, we invite you to share one of your critical processes for a free gap analysis against your provided standard. If you find that this analysis adds value to your process improvement and you are satisfied with our work, you can choose whether to appoint us as your third-party QMS consultant, following our service model.
The time required for QMS implementation depends on the size and complexity of the organization. The process typically takes between a few months and a year. We ensure efficient execution through close collaboration, detailed planning, and a clear roadmap.
Yes, we provide ongoing support, including monitoring, training, and continuous improvement services, ensuring your Quality Management System remains effective and compliant long after implementation.