Regulatory Services

SOP Writing

Quality Resource Solutions, LLC, understands the importance of in-depth and specific quality procedures in ensuring regulatory compliance and avoiding unnecessary expenses. Our SOP writing service provides businesses with clear, concise, and effective written processes that describe how to perform specific work tasks tailored to their operations.

Documenting standards properly not only ensures regulatory compliance but also enables effective training of personnel and encourages a culture of continuous improvement. Our team of experts has areas of expertise across various industries, including drugs, biologics, devices, diagnostics, nutraceuticals, dietary supplements, food, combo products, compounding pharmacies, and radio-pharma.

We are well-versed in the relevant regulations and guidelines, including clinical regulations such as 21 CFR Parts 50, 54, 56, 312, 314, 361, and 14155, manufacturing regulations such as 21 CFR Parts 210, 211, 111, 820, 600, 601, and 610, and Non-clinical regulations such as 21 CFR Part 58, Electronic Records and Signatures Regulations such as 21 CFR Part 11, ISO regulations such as 13485, 14155, 14971, 22716, 9000s, 62304, 15189, and 17025, ICH regulations such as Q7A, E6, and E2A, compounding pharmacy regulations such as USP 797, European Directives such as 2001/20/EC and 2005/28/EC, and Canadian Medical Device Regulations such as SOR-98-282

We work with you to develop customized SOPs that meet your specific needs and help ensure compliance with all applicable regulations and guidelines. Our SOP writing service can help your organization save time and money by reducing the risk of product redesign and reformulation while also improving training and promoting a culture of continuous improvement.

At Quality Resource Solutions, LLC, we are committed to providing high-quality SOP writing services that meet the unique needs of each of our clients. Contact us today to learn more about how we can help your organization develop effective SOPs and ensure regulatory compliance.

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