Clear and accurate communication can be the key to unlocking success in the regulatory approval process – or the closed door that significantly delays market introduction. ABR provides expertise and hands-on support to clients as they prepare documentation for regulatory submissions. Our medical writers work in partnership with our regulatory, clinical and biostatistics teams to provide the following medical writing services:

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• Clinical Evaluation Plans (CEPs)

• Clinical Evaluation Reports (CERs)

• Clinical Evidence Summaries (One-Page)

• Clinical Literature Review

• Clinical Study Reports (CSRs)

• Conference Abstracts

• Device Monitoring Reports (DMoR)

• Implant Cards

• Instruction for Use (IFU), User Guide, and Labeling (Creation or Editing)

• Investigator Brochures

• Journal Articles: Preclinical and Clinical Study Manuscripts for Submission to Peer-Reviewed Journals

• Labelling, Instructions for Use (IFUs), and User Manuals

• Period Safety Update Reports (PSURs)

• Quality, Security, and Usefulness Dossier for Combination Devices

• Scientific Publications and Conference Abstracts

• Summary (and Summaries) of Safety and Clinical Performance (SSCP)

• Systematic Literature Reviews and Associated Meta-Analysis

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