Company: 

Scandinavian Development Services

Scandinavian Development Services

Scandinavian Development Services Life Science was a leading consultancy in the Nordics with regards to regulatory guidance, design of clinical trials and expertise in biostatistics. Support services provided by NST included:

  • Investigational Medicinal Product Dossier
  • Investigator's Brochure
  • Scientific Advice/Briefing Books
  • Clinical Trial Application submission to the MHRA/BfArM
What our client said

"We found everyone at Niche to be polite, well informed and professional. They played an important role in all the projects they worked on and made their contribution in a capable fashion within the required scope and timelines. Management of the team is excellent, the native English-speaking writers provide confidence in the written documents they produce and fostered clear communication. Essential where teams are based in different countries."

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Anna Torner

Scandinavian Development Services




Project background
Scandinavian Development Services was a contract research company that provided specialised regulatory and statistical services to the pharmaceutical, biotechnology and medical device industries. It was focused primarily on regulatory affairs, clinical trials and market access to facilitate product development and maximise return on investment and efficient development. Scandinavian Development Services was known for its expertise in navigating the complex regulatory environments of Scandinavian and European markets, assisting companies in bringing their products to market efficiently and in compliance with local and international regulation. The company was acquired by Cytel Inc. in 2022.
Delivery

NST first started partnering with SDS in 2013. The NST team was invited to provide support for the development of the regulatory documentation for LIDDS AB Liproco depot and CicloMulsion. The NST team’s expertise in the preparation of Investigator's Brochures meant that it quickly and efficiently developed the necessary regulatory submission package.

Subsequent to the successful partnership, NST went on to provide medical writing, editorial and scientific support for development of a variety of scientific advice and other regulatory documents submitted to the MHRA and Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

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