Providing EU and UK regulatory, medical and clinical services to the pharmaceutical industry.
Based in West London in the United Kingdom, Swales Pharma Consulting is run by Dr James Swales, MB BS, an experienced pharmaceutical physician who spent six years as an Accredited Medical Assessor in the Licensing Department of the MHRA, the UK Medicines Regulator. He also has experience of working within the Pharmaceutical Industry within Global Clinical Development at Novartis as part of a team involved in a successful drug development and approval for a respiratory small molecule medicine and working a wider Medical Affairs/Clinical Innovation role in Global Consumer Healthcare at Johnson and Johnson.
Swales Pharma Consulting can provide consulting services across medical regulatory, strategic medical affairs and clinical development areas.
Get in touch to set up a consultation, or use the contact form at the bottom of this page to enquire about what services can be provided.
Areas of Practice
Medical regulatory
Whether a complex EU centralised application for an orphan indication medicine or a simple well established use application for an over the counter medicine, comprehensive regulatory support from a medical perspective can be provided. Services can include early regulatory planning, scientific advice, dossier construction and review to support during submission with questions.
Clinical development
Support can be provided for clinical development strategy, study design, data review and report authoring. This is available for New Chemical Entities as well as established actives and can be for single studies, bioequivalence or even full clinical development programmes.
Consumer Healthcare
Support for your consumer healthcare business from a medical, clinical and regulatory perspective. With extensive experience in Over the Counter medicines regulation as well as within the consumer pharmaceutical industry, all of your issues and requirements can be addressed.
Scientific Advice
Support with seeking of Scientific Advice from Regulatory agencies in the EU and UK. This can include strategic discussions about when to seek advice, what advice to seek, preparation and review of documents as well as attendance of meeting as an expert to make sure that the most is gained from the meeting.
Strategic Medical Affairs and Innovation
From working with marketing colleagues on claims ideation, support and review to innovation opportunity review, all bases can be covered. Working in medicines, devices and apps for prescription healthcare products or consumer healthcare any opportunities can be analysed and reviewed to allow for rapid and transparent decision making.
medicines Reclassification
Reclassification from prescription to over the counter or within the over the counter classification can be tricky. Support can be provided for your reclassifications in the UK and the EU. Review of opportunities, dossiers, scientific advice as well as examining the reclassification criteria from the perspective of your active can be supplied at any point during the process.
Let's Talk.
Use the form below to contact Swales Pharma Consulting regarding your enquiry. Please be as detailed as possible, include your industry along with any specific requests or requirements. To help us best service your enquiry, it is recommended that you first describe the issue you need help with before telling us what you want to achieve. You may also email or call us to make an appointment.