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.

Agneta has more than 25 years of experience with economy and administration. She is responsible for accounts payable, payrolls and manages reporting of financial data as well as internal administration. Customers and subconsultants will most likely come in contact with Agneta as she manages all our payments and invoicing.

Anna has more than 25 years of regulatory experience in pharma industries, both large companies and small research companies requiring close collaboration with functions such as QA, manufacturing, PV and Supply. Experience from company mergers as well as splitting companies, from launching new products in the Nordics, to LCM of mature single country products.

Charlotte has almost 30 years of experience within the pharmaceutical and medical device industries. The last 17 years as pharma regulatory affairs/CMC expert, working with product registrations, building dossiers, LCM of human and veterinary products, due diligence and regulatory strategies.

Christian has more than 20 years of experience in pharma industries, spanning roles in both large pharmaceutical companies and smaller firms. Proven expertise as regulatory manager also acting within quality assurance, and as a qualified person (QP).

Ellinor has over 10 years of experience of quality assurance and quality control in GMP and GDP from various pharmaceutical companies. Her expertise includes wholesale distribution of pharmaceuticals, including smaller companies with special arrangements, the development and maintenance of quality management systems, conducting audits and managing customer complaints.

Ellinor has 15 years of experience from the medical device industry in both leading QA and RA positions. Her experience covers QMS development and implementation, change and risk management as well as MDR compliance for class I–III products. Ellinor has worked with registrations of class III products in EU, the Middle East and African regions.

Emil has more than 25 years of quality and regulatory experience both with medical- and IV-devices of all classifications. Having worked with both large and smaller companies with business in Europe, US and Asia, Emil has implemented and improved several quality management systems/ eQMS and is a risk management expert as well as having extensive knowledge of supplier management and has participated in development projects and CE-marking of devices.

Helen has more than 20 years of experience in medical device including leading positions in product development, quality and regulatory. Experienced project leader for eg product development to CE marking, QMS development and implementation and regulatory strategies. Design control, risk management and R&D/production interface are some of the areas covered by Helen´s expertise.

Inga has nearly 25 years of experience in the pharma field, primarily within regulatory affairs but also medical information and pricing and reimbursement. As regulatory affairs manager Inga worked both with launch of new medicines and LCM of mature products. Previously she held positions as CMC assessor at MPA and more recently medical assessor at TLV (Swedish HTA body).

Kristina has more than 40 years of regulatory experience in large pharma industries, both marketing and research companies. At the research companies she held positions as project leader of regulatory teams, as well as regulatory responsible within global development projects. The last 14 years at Scandinavian Regulatory Services AB.

Maria has 20 years of experience of medical devices including 18 years from IVD. Her experience covers product development, risk management, usability, quality management, medical device software and regulatory affairs. Academic background with a PhD from Karolinska Institutet.

Marie has around 25 years of experience in office management and managing customer feedback and complaints. Marie is our dedicated office manager; she not only keeps everything running seamlessly but also creates a welcoming atmosphere in the office.

Mia has nearly 30 years of experience from working with GMP and GDP in the pharmaceutical industry, spanning both large companies and smaller firms. She has extensive expertise in building and implementing quality management systems, as well as serving in key roles such as QP working with batch release and RP on wholesale distribution authorizations/licenses. She is also a certified auditor.

Stella has over 15 years of experience in pharmacovigilance and regulatory affairs, providing expert support to clients across a wide range of PV needs. Her expertise includes case reporting, handling medical information inquiries, conducting literature reviews, delivering PV training, maintaining quality systems and overseeing post-market surveillance.

Viktoria has nearly 20 years of experience from regulatory affairs in the medical device industry. Her experience includes working for a notified body as well as medical device manufacturers of various classes and technology types, including medical device software and NMI products. Her primary focus has been the EU and North America markets, technical file compilations, regulatory submissions and strategies as well as audits and post market surveillance.