QUALITY & REGULATORY
Welcome to CGOC LLC, your go-to partner for Quality Management System (QMS), Regulatory, Quality Assurance (QA) Operations services. We understand that quality is essential for the success of any organization. That's why we offer comprehensive quality management services that ensure your products meet all regulatory requirements while maintaining the highest quality standards.
Our team of experienced professionals has extensive knowledge of the global regulatory environment, including FDA regulations, EMA guidelines, ICH standards, and other international regulations. We are committed to providing customized solutions to each of our clients to meet their unique requirements.
Our offerings include:
cGMP Compliance
We provide guidance and support to ensure compliance with FDA and international cGMP regulations, including 21 CFR 210/211 and ICH Q7, and 21 CFR part 111.
Audits and Inspections
We conduct internal and supplier audits and prepare companies for FDA and international inspections.
Process Improvement
We help businesses identify areas of inefficiency and develop strategies to optimize their processes. Our team will work with you to analyze your current processes and develop a roadmap for process improvement.
Quality Systems
We help companies establish and implement effective quality systems, including SOPs, CAPAs, and change control processes.
Validation and Qualification
We provide guidance and support for the validation and qualification of processes, equipment, and facilities.
cGMP Training:
We assist our client in training their employees on how to identify and prevent potential cGMP violations, cGMP related risks, hands-on training on how to implement cGMP regulations in pharmaceuticals, nutraceuticals and risk management.
Risk Management
We assist in the implementation of risk management strategies to mitigate potential issues and maintain compliance.
