Regulatory Compliance

Good Manufacturing Practices (GMP)

We strictly follow Good Manufacturing Practices in all aspects of our operations. Our manufacturing partners are selected based on their adherence to GMP guidelines, ensuring that the APIs we offer are produced under controlled and monitored processes.

Quality Control

Quality control is a key focus at Kyrene Global. We employ robust quality control measures to ensure that our APIs meet the specified quality standards. Our quality control team conducts rigorous testing and analysis to verify the identity, purity, and potency of our products.

Documentation and Traceability

We maintain comprehensive documentation and traceability records for all our API products. This includes batch records, certificates of analysis, and other relevant documentation to demonstrate compliance with regulatory requirements and enable traceability throughout the supply chain.

Regulatory Agency Audits

We welcome regulatory agency audits to ensure compliance with applicable regulations. We work closely with regulatory authorities and cooperate fully during inspections and audits to demonstrate our commitment to regulatory compliance and transparency.

Adverse Event Reporting

As part of our commitment to pharmacovigilance, we have established procedures for adverse event reporting. We actively monitor and report any adverse events associated with our API products to regulatory authorities as required.

By prioritizing regulatory compliance, we assure our clients that our products meet the necessary quality and safety standards. We continuously update our processes and adapt to changes in regulatory requirements to ensure that we stay at the forefront of compliance.

If you have any specific questions regarding our regulatory compliance or would like more information, please don't hesitate to contact us. Our team is dedicated to addressing your concerns and providing the necessary information you require.