Agneta Larhed has joined RegSmart AB as a senior consultant with focus on pharmaceutical development and quality/CMC. RegSmart is a newly started regulatory consultancy firm based in Uppsala.
Agneta has a broad experience within formulation development and regulatory quality documentation. In addition, she has been active as a manager and researcher within both industrial pharmaceutical innovation and product development and in academia. As a pharmaceutical assessor and, most recently, the scientific manager for pharmaceutics at the Swedish MPA, she has extensive knowledge about the assessment of quality documentation and important regulatory requirements.
About RegSmart: With our long regulatory experience from senior positions at the Swedish Medicinal Products Agency and small and big pharma we can guide you with advice on “what to do, when and how”. We provide fit for purpose advice and support in relation to EU and US regulatory requirements. Our focus is scientifically based strategic and operational regulatory support and advice to companies and academia from early research throughout the product lifecycle.