We are passionate about providing our clients with the best solutions for their unique engineering needs. Every project is executed with precision and expertise, ensuring the highest level of accuracy and efficiency. We are dedicated to building long-lasting relationships with our clients and committed to delivering exceptional service and quality work.
Solutions
X.0 Engineers is a premier Consulting Firm that specializes in engineering, GMP, QA and Validation Services.
Engineer Your Success with X.0 Engineers
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Auditing Services
Our Auditing Services are a comprehensive solution for owners, quality managers and regulatory affairs teams seeking compliance and quality systems consulting. We offer a range of auditing services, covering GMP Compliance, Regulatory Inspections, and Post-Audit Remediation Programs to meet EMEA and FDA standards. Our team of experienced professionals will work with you to ensure that your facilities and systems are compliant with industry regulations.
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GMP Consulting Services
At X.0 Engineers, we work collaboratively with our clients to develop innovative compliance strategy and solutions. We offer customized services designed to meet the unique and specific needs of our clients, including Compliance Strategy Development, Facility Design Reviews, and much more. Our team of experienced engineers is committed to delivering top-notch service, and we strive to exceed your expectations every time you work with us.
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Technical Writers
Our Technical Writers have a deep understanding of how to navigate the regulatory constraints of the Pharma industry while applying complex processes. At our Consulting Firm, we provide top-notch technical writing services that ensure your documents exceed industry standards. Our experienced professionals work together with you to deliver high-quality documents, on time, and within budget.
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Project Management
At our Consulting Firm, we offer an outstanding Project Management service designed to guide your business through every project phase, maximizing efficiency, time and resources. Our team of experienced professionals will work with you, from the development of the concept to the commencement of production, ensuring compliance with required regulations.
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Validation Services
Our Validation Services provide the validation your products need to meet regulatory requirements. Our team of experienced engineers offers a wide range of validation services, including cleaning and process validation as well as packaging validation. We prioritize quality and compliance in our work and strive to ensure that your products meet industry standards.
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Regulatory Affairs
At X.0 Engineers, we have a team of experts who specialize in regulatory compliance for prescription and over the counter products. Our regulatory strategy services include gap analysis, preparation, and submission of applications, as well as document preparation for clinical trials approval. We also offer GMP audit response assistance, including CAPA, to ensure your manufacturing facility’s compliance with all regulations.