Quality, Safety and Compliance

Quality Management & Quality Assurance

Excellence in Quality & Compliance

From the selection of qualified raw materials to the release of the finished API, WIELAND ensures compliance with all GMP requirements through a comprehensive quality management system. Validated processes, risk-based quality controls and complete documentation ensure product quality, safety and regulatory compliance.
Our quality organization oversees the entire manufacturing process, ensuring that our APIs consistently meet the highest international standards.

  • GMP-compliant manufacturing and quality control

  • Comprehensive Quality Management System

  • Qualified and validated processes

  • Regulatory compliance with international standards

  • Transparent documentation and traceability

  • Continuous improvement and risk management

Quality Control

State-of-the-art analytics, in-depth expertise and the highest quality standards

WIELAND’s API analytics provide validated data throughout the entire process – from raw material testing and process monitoring to release and stability testing – always in accordance with cGMP and ICH guidelines.

  • Modern laboratory and analytical equipment

  • Method development and validation

  • Release testing in accordance with pharmacopoeial specifications or individual customer requirements

  • Microbiological testing

  • Qualification of reference standards

Regulatory Affairs

Regulatory Lifecycle Management of APIs

With an experienced Regulatory Affairs team and an international network of specialized partners, WIELAND supports customers with regulatory projects worldwide.

  • Management of global regulatory approvals and registrations

  • Preparation and maintenance of ASMFs, DMFs and CEPs

  • Management of change control and registration processes

  • Coordination of international regulatory and customer requirements

  • Support during audits and inspections

Get in touch with WIELAND

Personal exchange and expert advice are important to us. Our experienced team is happy to assist you with any questions about our products and services.

Whether you need product information, have questions about regulatory requirements or have an individual request, we look forward to speaking with you directly.

Please feel free to get in touch. We are here for you.

Alexander Wörner
Alexander Wörner
Managing Director
WIELAND Pharma