Quality Assurance

Asymchem’s Quality Management System (QMS) is a robust and comprehensive framework designed to ensure our products meet the highest quality standards, whether for clinical phases or commercial production. It covers all stages of production, from raw material procurement to final product distribution, guaranteeing compliance with regulatory requirements and industry best practices. The QMS is focused on minimizing risks, enhancing product safety, and ensuring efficacy through well-defined processes for quality assurance, quality control, and continuous improvement. By fostering a strong culture of quality, Asymchem’s management team ensures that our QMS supports clients in delivering safe, effective, and high-quality medicines to patients.

Our Quality Assurance Team

Our team of dedicated quality professionals brings over 25 years of experience in clinical and commercial GMP environments within the pharmaceutical industry. In addition, we possess extensive expertise in overseeing outsourcing partnerships with CDMOs, which provides us with valuable insight into our clients' specific needs. With a combination of technical knowledge, integrity, and practical experience, we are well-equipped to support the quality of the GMP activities you entrust to us throughout the entire lifecycle of your projects.

Regulatory Guidelines

Exceeding Global Standards with Robust Quality Management and Compliance

As part of our commitment to the highest quality standards in all aspects of our operations, Asymchem has successfully implemented our Quality Policy and Management System, ensuring compliance with cGMP and ICH Q7/Q8/Q9/Q10/Q11, as well as 21CFR 211/210 guidelines. As a result, we meet or exceed regulatory requirements of the USFDA, the EU, the UK and other countries.