About | GxP

President and Principal Auditor

Kristy Rodriguez

With over 25 years of experience in auditing within the financial and pharmaceutical sectors, Kristy Rodriguez (Paulick) possesses a wealth of expertise. Her focus during the past 15 years has revolved around Clinical Research, fostering extensive familiarity with GxP regulations, ICH guidelines, and regulatory directives. She stands out as a self-motivated, detail-oriented individual who excels in independent work, leadership roles, and seamless integration within team environments. Her diverse experience spans conducting audits of sites, vendors, and laboratories, training, facilitating regulatory inspections, as well as providing inspection readiness on a global scale for regulatory bodies like the U.S. Food & Drug Administration (FDA), Health Canada, European Medicines Agency (EMA), Medicine and Healthcare products Regulatory Agency (MHRA), and Medicines Control Council (MCC). Additionally, she has served as a QA Director in-house at both small biotech companies and large pharmaceutical corporations.

At the core of Kristy's professional ethos is a commitment to excellence. She thrives on navigating the complexities of regulatory landscapes, conducting meticulous audits, and providing strategic guidance to organizations striving for compliance.

As the proud founder of The GxP Advisors, Kristy and her team are excited to contribute their skills and knowledge to further elevate your organization's commitment to quality assurance and regulatory compliance. Together, the team aims to ensure the safety, efficacy, and compliance of products within the life sciences sector.

Our Services

Auditing Services

Our auditing services are designed to meet your GCP, GLP, and GMP requirements, offering thorough and comprehensive evaluations to maintain the highest standards in these areas. Whether it involves clinical sites, CROs, bio-analytical labs, drug depots, or other domains, you can rely on us to conduct meticulous audits that are customized to your specific needs. Our goal is to enhance compliance and foster excellence in your operations through our dedicated auditing services.

Training

Unlock the potential of your team through our diverse training offerings. From mastering GxP fundamentals to navigating Mock FDA Inspections, we specialize in empowering your staff to elevate their performance and contribute even more to your organization's compliance. Let us be your training partner, shaping a workforce that works smarter and harder for you.

Inspection Readiness

Inspection readiness is a critical aspect for organizations in regulated industries. To navigate the rigorous scrutiny of the FDA, EMA, etc., proactive measures and strategic preparations are essential. Our team can visit your site, meticulously review your records, ensure compliance, and conduct comprehensive training for your staff in preparation for the impending inspection. Let us fortify your readiness and support you through this crucial regulatory process.

Inspection Facilitation

Conducting an FDA inspection demands a strategic approach to guarantee a seamless and successful interaction with regulatory authorities. Our expertise lies in meticulously preparing your site and staff for this crucial process. Let us guide you through the intricacies of an FDA inspection, ensuring transparency and a smooth journey throughout the inspection proceedings.

Quality Support

We provide comprehensive quality support through various avenues. Whether it's crafting Quality Manuals, creating Standard Operating Procedures, developing Audit Programs, or offering a range of other services, we are dedicated to ensuring excellence in quality management.

Interim Quality Roles

Are you in need of a Quality Director or support staff to bridge the gap until you find the ideal candidate? Let one of our team members step into the interim role, providing the support you need and giving you the time to conduct a thorough recruitment process.

Looking for a difference service?

If you have additional quality or GxP related needs that aren't mentioned here, please don't hesitate to reach out. We are here to explore how we can further assist you. Your satisfaction and success are our priorities.