We are ISO 9001:2015 certified.

We have a quality system that addresses the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

We have written procedures for SOP and other document change control.

We provide notification to the buyer on a timely manner and each time when a process, equipment or    analytical method change, affecting the regulatory status.   

We have a documented procedure for corrective and preventive action (CAPA).

We inspect the environmental control systems periodically and such inspections documented.

We perform on regular time intervals self-inspections and records are kept of such inspections.

We purchase raw materials from qualified suppliers only.

We perform on regular time on-site audit of our raw material suppliers.

We inspect materials upon receipt to confirm the conformance to the specification.

We have agreements with suppliers that commit them to notification of proposed changes on a component or service

We follow ICH Q7A Guidance.

We operate our own quality control laboratories.

We train our employees and operators regularly.

We supply products conforms to agreed specification.

We have a system to assure that only products approved for release are distributed.

We have a label control system in place.

We control and monitor the storage conditions.

We pack and deliver the goods strictly according to the buyers’ instruction.

We supply a Certificate of Analysis with each delivery batch which states all analysis data.

We submit the shipping documents to the buyer for customs clearance as soon as the goods dispatched.

We keep retain-samples of all production batches for future reference.

We maintain product stability/retest data for our products.

We are responsible for the quality claims of all products we sell.