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SRS offers the service to thoroughly analyze the regulatory status of medicinal products and medical devices.
We determine whether products are marketable in terms of regulation requirements, and judge the quality of documentation for the products to say whether the product's documentation is consistent and in compliance with the requirements and current practices of local and national regulations.
We also provide the service to assess quality systems for conformance with GMP or GDP for pharmaceuticals and EN ISO 13485 or Quality System Regulation (QSR) for medical devices.
Please feel free to contact me to discuss how we can support you.
Phone: +46 8 544 767 91
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