At GZ 21st Century GXP Auditing & Regulatory Consulting Services, our vision is advancing safe and reliable access to the world’s life-saving products by helping companies comply with evolving global regulatory requirements.
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With decades of hands-on Quality, GXP Auditing and Regulatory Strategies development experience in a global regulatory landscape, our experts assist biotechnology, vaccine, pharmaceutical and device companies, to gain and maintain regulatory approval. We provide strategic, tactical, and operational direction and support in every stage of product lifecycle by conducting value added GXP audits, creating sound regulatory strategies, ensuring regulatory inspection readiness; and coordinating the company’s response to inspection results.
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Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat.
Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.
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GZ 21st GXP Auditing and Regulatory Consulting Services was founded in 2017 by an independent consultant Gezahegn Z. Mengistu (known in the industry as GZ), who has over 25 years of hands-on experience in GXP audits, quality management, regulatory compliance, and interpretation; and manufacturing within global regulatory landscape.
Over two decades of experience in leading GXP audits on behalf of global biopharmaceutical companies in US and Europe and leading GMP Compliance Organizations with mandates of global regulatory landscape, gave birth to a niche consulting firm, which offers focus & specialization, pragmatism & implementation; and flexibility.
GZ wanted to bring his over two decades of in-depth expertise together with other top caliber execution-focused experts in the industry, to establish a consulting company, built on providing tailored, practical, and proven solutions to evolving regulatory compliance challenges, anywhere in the world at any stage of biopharmaceutical product lifecycle.
We provide GXP audits, inspection readiness, creation of regulatory strategies, training and other quality assurance services for established/startup companies engaged in manufacturing of biotechnology, pharmaceutical, vaccines, medical device, and combination products.
At GZ 21st GXP Auditing and Regulatory Consulting, our goal is to assist companies gain and maintain regulatory approval by sharing our decades of proven hands-on experience to their unique regulatory and compliance situation. Being smaller consulting firm, we have earned reputation for providing quality services using in-depth specialized expertise on a cost-effective basis. It is our desire to earn and maintain your trust and become your go to partner when you need GXP Auditing and Regulatory Consulting support.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique.
Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat.
Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique.
Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat.
Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.
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We go deep to unlock insight and have the courage to act.
We bring the right people together to challenge established thinking and drive transformation. We work with our clients to build the capabilities that enable organizations to achieve sustainable advantage. We are shaping the future. Together.
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Legal consultant
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Business consultant
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Business analyst
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Logist
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Executive Director
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Manager
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Lawyer
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Business analyst
We work for a wide variety of clients in both the private and public sectors.
A business strategy is the means by which it sets out to achieve its desired ends. A business strategy is the means by which it sets out to achieve its desired.
A business strategy is the means by which it sets out to achieve its desired ends. A business strategy is the means by which it sets out to achieve its desired.
A business strategy is the means by which it sets out to achieve its desired ends. A business strategy is the means by which it sets out to achieve its desired.
A business strategy is the means by which it sets out to achieve its desired ends. A business strategy is the means by which it sets out to achieve its desired.
A business strategy is the means by which it sets out to achieve its desired ends. A business strategy is the means by which it sets out to achieve its desired.
A business strategy is the means by which it sets out to achieve its desired ends. A business strategy is the means by which it sets out to achieve its desired.
