We provide GxP (GMP, GCP, GLP, and GDP) auditing and regulatory consulting services for established/startup companies engaged in the manufacturing, testing and distribution of Gene Therapy, Cellular Therapy, Biotechnology, Combination Products, Vaccines, Oral Solids, and Active Pharmaceutical Ingredients within the global regulatory landscape.
We put our decades of proven in-depth knowledge of global regulatory requirements and expertise to work for you throughout the product lifecycle. With our top caliber GxP compliance and regulatory professionals, we can rapidly deploy GXP audits and regulatory consulting services, for any project, anywhere in the world.Our GxP compliance experts conduct GxP audits on your behalf to demonstrate commercial manufacturing readiness, conformance to application or protocol, data integrity audit, enable certification of product by qualified person (QP), compliance with applicable regulatory requirements, or routine monitoring of compliance of your pharmaceutical quality system with CGMPs.
In addition, our Regulatory Affairs professionals provide both strategic and operational levels support for global regulatory submissions.
We work for a wide variety of clients in both the private and public sectors.
We conduct value added GXP audits of Contract Acceptors on behalf of our established or startup companies engaged in manufacturing of gene therapy, cellular therapy, biotechnology, pharmaceutical, vaccines, device, and combination products. Our GXP audits include supplier selection, evaluation, approval, and oversight; as well as due-diligence in support of in-licensing and out-licensing activities. In addition, we can supplement your internal audit program by performing value added audits in compliance with regional and global regulatory requirements.
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Our United States Agents can also act as official correspondents for Foreign Device Establishments to assist FDA with Foreign Establishments, respond to questions concerning foreign establishment’s products that are imported or offered for import into the United States, and assist FDA in scheduling inspection of the foreign establishments.
Our experts are experienced in preparing sites for health authorities pre-approval inspections to demonstrate commercial manufacturing readiness, conformance to application or protocol, and to data integrity principles. We provide end-to-end “mock” regulatory agency inspection services. Our clients can count on us to be ready for regulatory agencies’ inspection efficiency approach post COVID-19 pandemic.
We provide on-site or off-site training in GXP Auditing and Principles of Data Integrity (prevention, detection, and reporting). In addition, we provide refresher training on basic GMP Auditing.
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"We are lucky enough to dare to open our own business and turn for help to real professionals. We have been successful thanks to Efito 128»
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"We are lucky enough to dare to open our own business and turn for help to real professionals. We have been successful thanks to Efito 128»
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"We are lucky enough to dare to open our own business and turn for help to real professionals. We have been successful thanks to Efito 128»
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