I’m working with a number of clients at present providing quality consultancy in the following areas:
Client 1 The improvement of their Quality Management System as they look to bring in-house the release of their drug – device product.
Client 2: Advice and guidance in relation to the building of a new facility for Advanced Therapeutic Medicinal Products.
Client 3: This client manufactures novel vaccines for early stage clinical trials. I am providing assistance in the following areas:
- updating their Quality Management System;
- assisting with qualification and validation of utilities and computerised systems;
- supplier audits;
- QP certification and release of product to clinical trials.
Client 4: Advice on QP issues related to gene therapy products.