Updated MHRA Scientific Advice Process (+ case study)

Why might I need a Scientific Advice Meeting? Do you have any questions for the MHRA about the clinical development of your medicine, strategy for a Marketing Authorisation Application (MAA) or looking at a reclassification?  Then you may benefit from a scientific advice meeting (SAM) with the MHRA.  This article provides an outline of where […]

SME status in the UK

Are you a small or medium-sized enterprise (SME)? If so the Medicines and Healthcare Products Regulatory Agency (MHRA) fees legislation currently has provision for some payment waivers for SMEs. What is the criteria for a small or medium company? The criteria that needs to be met in the UK in order to be defined as […]

International Expansion

We welcome Sue Allen, Senior Regulatory Affairs Consultant, to discuss the practical considerations of international expansion and the questions that should be asked during the planning and execution stages of licencing your pharmaceutical products globally. As developed markets continue to stagnate, emerging markets are becoming even more important as a source of revenue growth for […]

Compliance Culture

It is our pleasure to introduce Julie Yeoman as one of our guest bloggers, who writes so passionately about compliance and visits the core of company culture, an interesting angle in such a process driven industry. Working in the field of healthcare compliance for over 20 years, Julie starting her career with AstraZeneca where she […]

Early Access to Medicines Scheme

The early access to medicines scheme (EAMS) was introduced by the MHRA with the objective of providing patients with life-threatening or seriously debilitating conditions, access to medicines that have not yet received a Marketing Authorisation and addresses an unmet medical need. Since the scheme was launched in 2014 over 1,200 people from across the UK, […]

The Importance of Cross-functional Working – a Marketing Perspective

We are delighted to introduce Michelle Bridgman who brings along with her 10 years of experience working as a Pharmaceutical Brand Marketer with Prescription Medicines, OTCs and Medical Devices. Michelle understands well the benefits and importance of cross-functional working and discusses this here in more detail and from a Marketing perspective.   We are all […]