Preparation and regulatory submission documentsReviewers from the relevant authority read the submitted paperwork without knowledge of the product. It is therefore very important that the documents describe the device, its R&D background and the intention of the submission clearly and logically. Otherwise, the reliability of the documents may be called into question, which may in turn affect communication between the reviewers and the applicant. Our experienced consultants make every effort to maintain closed communication with clients in order to understand the device and to collect the information required to field potential questions from the authority.
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