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Erika Spens Email
Director Regulatory Affairs . SDS Life Science
Danderyd, Stockholm
Locatione**********@sdslifescience.com
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SDS Life Science, Consultants in Drug Development, Medical Device and Statistics. In Scandinavian Development Services (SDS) we are specialized in regulatory and scientific knowledge in drug development, medical device and statistics. Our ambition is to guide our clients in transforming their research hypotheses into full clinical studies. We provide expert advice on formulation development, planning of both clinical and non-clinical programs, as well as medicinal product development. Our experienced project managers can provide all the required support and oversight of activities for the program, including writing the protocols and technical documentation. We have experts in writing high quality clinical reports that meet the authorities’ standards. Our trusted team of regulatory experts can act as communication mediators with the regulatory authorities, such as Notified Bodies. In collaboration with our regulatory experts, our accomplished statisticians adopt a holistic approach to help our clients to conduct statistically well-designed studies in accordance with the regulatory standards. Taking advantage of SDS strong expertise in medicinal products and biostatistics we can expand our services to combination products (drug-device/biologics-device), medical devices for in-vitro diagnostics or to products for which the applicable regulation is not well-defined. We are passionate about solving those tricky questions which have no obvious answers. We always stay curious, and we always strive to update our scientific knowledge. We have it all!SDS Life Science Address
Svärdvägen 23Danderyd, Stockholm
SWE