The GxP Advisors were founded by Kristy Rodriguez in 2023. After owning her own Consulting Firm, KLP Consulting, where she worked as a solo consultant for fifteen years, she decided to form a company where she could partner with other individuals with similar knowledge and experience to offer clients a broader range of services.
The GxP Advisors team is a group of highly skilled and dedicated professionals committed to ensuring the highest standards of compliance and quality within the life sciences industry. With a collective expertise spanning diverse areas such as pharmaceuticals, biotechnology, medical devices, and Contract Research Organizations (CROs), our team brings a wealth of experience to every collaboration.
Yes, our team is available for remote audits. Since the pandemic affected all of us in 2020, as an industry we have reevaluated how we conduct audits. We are amenable to performing remote audits if the scope and circumstances permit.
Yes. All of our Auditors are prepared with valid passports, able to travel internationally, and are willing to obtain the necessary visas when required.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
Good Documentation Practices, commonly referred to as GDPs, are the guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner.
Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
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