Anki has more than 30 years of experience within QA and RA from several medical device and pharmaceutical companies. Working as head of RA/QA as well as working directly with regulatory tasks in support of product development of medical devices, IVDs and combination products for EU and US. Since more than 10 years Anki is the managing director of SRS. Currently acting as head of pharma regulatory.

Karin has almost 20 years of experience from regulatory affairs from several medical device companies, working with product development, regulatory compliance, registrations both in and outside of EU, medical device vigilance and quality assurance. Project lead and strategic expert.

Azi has 15 years of experience in Quality Assurance within GMP and GDP environments in the pharmaceutical industry. Her expertise includes manufacturing, distribution, auditing, training, development and implementation of quality systems. Her GMP experience includes the manufacturing of solid and semi-solid dosage forms and sterile products, including batch certification of biologicals and vaccines as QP.

Anna-Karin has 25 years’ experience from the pharmaceutical industry, covering regulatory CMC for development products, new applications and life cycle management for both small molecules and biologics. She has expertise from working with a wide range of markets; EU, US, Middle East and Asia (including China and Japan), at small and large pharmaceutical companies. Anna-Karin has worked with different product types from orphan drugs to generics and navigated key EU procedures such as centralised and mutual recognition.