our quality system meets the cgmp requirements of leading regulatory bodies
quality comes first
As a biopharmaceutical manufacturer with more than 30 years of experience, we are keenly aware of our responsibility to patients and ensure the highest standards of quality in biopharmaceutical production.
Our Quality Management System is set up according to international standards (EU- and US-GMP and ICH guidelines), it is based on quality risk management with the principal of continuous improvement. Quality is an integral part of our daily project work: when starting with implementation of your project we consider already the needs to manufacture according to GMP for early clinical phases up to commercialization. It is the Quality Management System by which we assure to deliver the quality needed for your project with sufficient flexibility for product specific adaptations and to meet regulatory expectations throughout the life-cycle of your product.
All our sites have the respective GMP-certification from the local authorities. Our long history of inspections by international bodies is listed below, numerous audits buy our customers are part of our daily business.
The team of Richter-Helm BioLogics strives to continuously improve our services, internal standards, and business systems for meeting the expectations of both external and internal clients and complying with relevant regulatory requirements throughout each product’s lifecycle. We communicate our quality policy to the organization and translate it into internal standards that are consistently taught, understood, applied, and followed.All our sites have the respective GMP-certification from the local authorities. Our long history of inspections by international bodies is listed below, numerous audits buy our customers are part of our daily business.
Audit History by Regulatory Agencies and Clients
For every customer project we have an in-house quality assurance expert of Richter-Helm BioLogics assigned to the project team and designated QPs on site that perform release of the Drug Substance batches based on our batch record review procedures.