Quality and Regulatory Overview

Quality assurance, quality control and regulatory affairs

Quality Control

At each of our sites, the Quality Control group operates a stringent system for release testing of raw materials, packaging materials, in process controls and final products through the use of the most modern analytical techniques and equipment supported by highly trained and experienced personnel.  QC also undertake reference standard certification in compliance with cGMP regulations.

Quality Assurance

At each of our sites, the Quality Assurance group, independent of production, is responsible for the maintenance, compliance and further development of our internal quality management system. The Quality Assurance group guarantees that the pharmaceutical ingredients and other products comply with the respective requirements and are developed, produced, tested and released according to cGMP demands.

Regulatory Affairs

Dishman support customers through New Drug Application (NDA) to in-market supply. We assist our clients with regulatory filing processes by providing full support in the compilation and maintenance of regulatory documentation including chemistry, manufacturing and control documentation, post-approval change documentation, type II Drug Master Files (DMFs), Certifications of Suitability to the Monographs of the European Pharmacopoeia (CEPs) and Active Substance Master Files for Europe (ASMFs).