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"With regular demand for our product Ketensin in the Netherlands, we required a contract manufacturing partner that could not only sterile fill into various sizes of vials and test the finished products, but that could reliably deal with smaller commercial quantities. We have been impressed by the customer interaction, willingness and technical ability demonstrated by SCM Pharma and look forward to working with the team on an ongoing basis." David Traynor Senior VP manufacturing and pharmaceutical sciences, ProStrakan
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SCM SECURES MHRA APPROVAL
16 March 2009

SCM Pharma has once again passed its biennial inspection from the Medicines and Health Care Products Regulatory Agency (MHRA).

The successful audit means the UK-based company will continue supplying products for clinical trials and commercial pharmaceutical projects from its state-of-the-art cGMP-compliant manufacturing, development and packaging facility.

The MHRA audit is a requirement of the European Union Clinical Trials Directive (2001/20/EC) and it means SCM can continue working on its clients’ Investigational Medicinal Products (IMPs) for pre-clinical, Phase 1/II/III and commercial stages.

Jennifer Watson, quality manager at SCM Pharma, said: “We are delighted to have once again been approved by the MHRA. The news is testament to the ongoing commitment of all staff on site to work to standards well beyond the industry norm.”

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