Overview of our services from the founder

Welcome to 21st Century GXP Auditing & Regulatory Consulting Services, your Trusted Partner for End-to-End Quality, GMP Compliance, and Regulatory Solutions.

As members of one of the premier Quality, Compliance, and Regulatory consulting firm,  our team of seasoned consultants combines their hands-on industry expertise with a deep understanding of evolving regulatory requirements to deliver tailor-made solutions that add value to your organization, satisfy stakeholders, patients, and regulatory authorities alike.

Our Vision: Pioneering Safe and Reliable Access to Life-Saving Products

Our vision is to advance safe and reliable access to life-saving products by assisting companies in complying with the ever-evolving global regulatory landscape.

Our Comprehensive Services

We specialize in providing GxP (GMP, GCP, GLP, and GDP) auditing and regulatory consulting services to both established and startup companies involved in the manufacturing, testing, and distribution of various products, including Gene Therapy, Cellular Therapy, Biotechnology, Combination Products, Vaccines, Oral Solids, and Active Pharmaceutical Ingredients across the global regulatory arena.

Our team leverages decades of proven, in-depth knowledge of global regulatory requirements to support you throughout the product lifecycle. With our top-tier GxP compliance and regulatory professionals, we can swiftly deploy GXP audits and regulatory consulting services for any project, anywhere in the world. Our GxP compliance experts conduct audits to ensure commercial manufacturing readiness, compliance with application or protocol standards, data integrity, certification by a qualified person (QP), adherence to applicable regulatory requirements, or routine monitoring of your pharmaceutical quality system's compliance with CGMPs.

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Our Exclusive Services Include:

GXP Audits: We conduct value-added GXP audits of Contract Acceptors on behalf of established and startup companies engaged in the manufacturing of various products. Our audits encompass supplier selection, evaluation, approval, and oversight, along with due diligence for in-licensing and out-licensing activities. We also enhance your internal audit program by conducting audits compliant with regional and global regulatory requirements.

Regulatory Inspections Readiness Support: Our experts excel at preparing sites for health authorities' pre-approval inspections, ensuring commercial manufacturing readiness, compliance with application or protocol standards, and adherence to data integrity principles. We offer end-to-end "mock" regulatory agency inspection services, guaranteeing readiness for regulatory agencies' inspection efficiency approach post-COVID-19.

Training: We provide on-site or off-site training in GXP Auditing and Principles of Data Integrity (prevention, detection, and reporting). Additionally, we offer refresher training in basic GMP Auditing.

United States Agent: We serve as United States Agents for foreign establishments involved in the manufacture, preparation, propagation, compounding, or processing of devices imported into the United States. Our agents also act as official correspondents for Foreign Device Establishments, assisting the FDA with foreign establishment-related inquiries and inspections.

Why Choose Us:

Strategy: Our consultants work closely with clients to craft customized action plans tailored to their unique situations. They possess insights into regulatory agency expectations and trends, helping companies stay ahead of regulatory changes and adapt their strategies accordingly.

Deployment: We deploy expertise-based consultants globally to quickly drive project success. Our efficiency and focus lead to faster results and resolution of compliance issues, often at a lower cost than hiring and training full-time staff.

Our People: Our experienced senior consultants offer in-depth expertise and specialized knowledge, delivering practical solutions and enhancing your organization's long-term compliance capability.

Implementation: We develop and implement practical solutions aligned with the latest standards, mitigating compliance risks, and preventing regulatory violations.

Choosing our regulatory compliance consulting services means selecting a trusted partner dedicated to safeguarding your reputation, ensuring patient and consumer safety, and driving your success in a highly regulated world. Our experienced consultants offer specialized knowledge, objectivity, efficiency, and cost-effectiveness that can significantly benefit your organization.

While internal resources are vital, our consultants bring a unique skill set and perspective invaluable for achieving and maintaining regulatory compliance. They play a crucial role in risk mitigation, continuous improvement, and ensuring your organization operates in line with the highest industry standards.

Partner with us to chart a course towards regulatory excellence. Contact us today to learn how our expertise can empower your organization's compliance journey.

Visit our website at https://www.gzglobalhealthcare.com/ to explore our full range of services and connect with us for a consultation.

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