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Regulatory

Mentara provides expert regulatory consultation, support, and representation with the FDA, Health Canada, European and other international regulatory agencies.  We can help your company determine the best strategy for product development and also provide you with operational support, including technical writing, for all your submission requirements.

Mentara has expanded its Regulatory Services to support electronic regulatory submissions. Our consultants can work seamlessly with your project team to provide efficient, cost-effective electronic publishing services to convert current paper submissions, and to format new submissions to compliant eCTD submissions.

Mentara provides the following electronic and paper publishing services:

  • Introduction and orientation to the electronic Common Technical Document (eCTD) and CTD and document granularity
  • Generation of easy-to-use templates in MS Word to minimize revisions (includes pre-formatted tables for entry of tabular data, style sheets to maintain continuity in the use of abbreviations, italics, units of measure, and symbols)
  • A roadmap to the required regulatory guidances to direct authors’ input
  • Assessment, consultation, and/or authoring of submissions by our scientific and clinical experts
  • Clean-up of any files provided in MS Word (includes basic formatting, table of contents generation, if required, insertion/validation of table/figure captions and cross-reference linking, and intra-document links as required)
  • Conversion of files to PDF for both paper and electronic publishing)

A good regulatory strategy, implemented from conception through clinical trials, can minimize both delays and additional costs necessary to remedy deficiencies.