Regulatory Consultancy
PharmOut Limited was set up in 1998 and is run by Tracey Upchurch, a Regulatory Affairs professional with 19 years’ international regulatory experience of working with a wide range of companies and clients, including blue-chip multinationals and small consultancy organisations.
Key Areas of Experience
- Strategic Regulatory advice, liaison with authorities;
- Marketing Authorisation Applications, response to Licensing Authority questions, variations;
- Dossier compilation, including clinical overviews (working with PharmDoc) and quality overall summaries;
- Pharmaceutical, biological and modified release products, over a wide range of therapeutic areas.
