Complete adherence to regulatory compliance guidelines and GMP is fundamental to everything we do at Symbiosis. There is no room for error when it comes to manufacturing injectable drug products intended for patient studies, which is why it is taken so seriously.
We currently hold both a commercial manufacturer/importer’s license for the GMP-manufacture of aseptically-filled licensed commercial products and an Investigational Medicinal Product (IMP) license. In our last MHRA inspection (July 2015), we received no critical or major observations.
The sterile filling of drug products is no easy task, hence the limited amount of injectable facilities remaining in the world. Running such a business comes with high set-up and maintenance costs for facilities, requirement for specialist expertise, complex process control and validation requirements. It also comes with the necessity for a quality driven culture from the top.
As a business, sufficient importance is always placed on investment in compliance with the latest regulatory guidelines. We strive to meet the gold standard of regulatory guidelines demanded by the MHRA both now and in the future. We are focused on absolute GMP compliance, remaining vigilant with respect top the newest emerging regulatory requirements and preserving our quality-driven business culture.
We maintain a frequent and constructive relationship with the regulators, through the development of an internal ‘right first time’ compliance culture and by respecting the business-critical need to comply given that GMP lies at the heart of our service offering. The rules are strict but we believe this is rightly so in the interests of patient safety, which is essential.
As a specialist CMO, we are ideally positioned to handle the challenges of sterile manufacturing because it is our core business and we make the relevant investments to assure quality.