Fusion Chat

We are delighted to host Dr Donna Lockhart within our Fusion Chat series, interviewed by Leah Heathman at Fusion Pharma. Donna is a highly respected independent medical, clinical and regulatory consultant to the pharmaceutical and medical device industry and is the Managing Director of Hurst Grange Associates Limited. Previously Donna has written a blog for […]

Quality and manufacturing strategy during product development planning

During 30 years’ experience in medicines and device development it has been my observation that insufficient attention is paid to the importance of quality and manufacturing strategy during product development planning. In particular, the need to generate the required information for submission in regulatory applications. The focus early on is placed firmly on clinical development. […]