QP (Qualified Person)
Our GMP compliance team includes a number of QPs experienced in the manufacture of a wide range of novel biotherapeutic molecules and Advanced Therapy Medicinal Products.
Our QPs are contracted by many of our clients to perform the legal responsibilities of a QP as defined by EU legislation.
Uniquely, our consultant QPs combine experience across both operational and capital projects making them suited to evaluating technologies and manufacturing processes, assisting with process and analytical development and ensuring GMP compliance from the early initiation phases of a concept design all the way through to the final operational and regulatory licensing of a manufacturing facility.
Through this engagement, our QPs have built a strong relationship with the UK’s MHRA and have experience with other competent authorities within the EU and USA. Their combined experience provides an unrivalled knowledge and expertise of working within the challenging and exciting world of ATMPs.