Technical Assistance

Regulatory CMC Support (Chemistry, Manufacturing & Controls)

For Life Sciences organizations, robust CMC services are essential for regulatory compliance. At Registitute, we offer:

  • Strategic CMC dossiers aligned with ICH CTD/eCTD standards

  • Gap analysis & global strategy tailored to specific regional requirements (FDA, EMA, MHRA, SFDA…)

  • Full-scale dossier creation, including Quality Overall Summaries (Module 2.3) and Module 3 content

  • Conversion & submission in eCTD and NeeS formats (IENs, INDs, ANDAs, NDAs, MAA, DMFs) 
  • Drug Master File preparation, management, and conversion (Type II DMFs with eCTD support)
  • Lifecycle support: amendments, annual reports, variations, deficiency responses

Benefits: Reduce regulatory risk · Improve dossier quality · Streamline submission timelines

eCTD & NeeS Submission Readiness

  • eCTD expertise: structure, XML backbone, document navigation, validation checks 
  • NeeS support: non-eCTD electronic submissions with full compliance
    Quality publishing services: document formatting, bookmarks, hyperlinks, QC, archival

Outcome: Submission-ready packages that meet FDA, EMA, and other authority requirements — efficiently track lifecycle sequences

MedTech Technical Documentation Templates

  • Modular and customizable templates for Site Master Files, SOPs (Risk Management, Change Control), and key regulatory reports
  • Ready-to-use drafts for CERs, PMSRs, PSURs—designed for rapid adaptation

  • Expert guidance simplifies content creation vs. formatting hassles

Best Practices & Quality Enhancement

  • Regulatory documentation optimization: quality by design, metadata integrity, seamless WHO/ICH/FDA alignment

  • Workflow efficiency: robust processes and tools reduce errors and accelerate time-to-market

  • Continuous improvement: template updates and process refinement across project lifecycles

We offer a comprehensive solution to simplify the creation of technical documentation/ Site Master File for Medtech. We provide a range of ready-to-use templates that can be customized to your specific needs, allowing you to focus on the content rather than the format.
Our templates cover a wide range of requirements, from SOPs such as Risk Management and Change Management, to specific reports like Clinical Evaluation Reports (CERs), Post-Market Surveillance Reports (PMSRs) and/or Periodic Safety Update Reports (PSURs).

With our support, you can ensure that your technical documentation is of the highest quality, meets regulatory requirements, and is ready for submission.

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