Pharmaceutical Deliverables
The Regulatory & Medical Writing Matrix is an interactive reference for all regulatory and medical writing deliverables Criterion Edge produces across the product development lifecycles for the medical device, in-vitro diagnostic device, and pharmaceutical industries. You can use this tool to ensure a complete portfolio of regulatory and medical writing documents across the lifecycle of your product, create a list of deliverables for the project team, and ensure you are meeting product lifecycle requirements.
Click the work streams at the top of the tool to load that set of documents.
Click any row (or the arrow next to the document name) to expand a full description. Click again to collapse.
Type into the search box at the top of the tool to find any deliverable. Results group by work stream. Click a result to jump straight to it.
Use the Service Area dropdown at the top of the tool to jump between Medical Device, Pharmaceutical, In Vitro Device, Systematic Literature Review, and Publications & Med Affairs.
All deliverables/documents are grouped by workstream. You can browse documents by clicking on the workstream at the top of the table and get a detailed explanation for the individual documents by clicking on the arrow next to that document name. Each workstream is broken into lifecycle stages. The bar for each document is shown across the lifecycle stages that it is relevant for. The boxes below describe the use and structure of the bars on the matrix.
Tells you which lifecycle stage the deliverable belongs to. A bar in the leftmost column happens early; a bar in the rightmost column happens at submission or post-approval.
A bar filling one column marks a point-in-time deliverable. A bar filling multiple adjacent columns means the document is drafted, updated, or referenced across several lifecycle stages.
Dark navy bars are submission documents (the primary regulatory output of that stage). Light blue bars are supporting documents that feed into or accompany the submission.
Our Service Areas
Criterion Edge offers specialized writing services across the entire product lifecycle — from regulatory submissions and clinical development to post-market obligations and strategic communications.
EU MDR · FDA 510(k) · PMA · De Novo
Comprehensive regulatory writing across the full medical device lifecycle — from IDE applications and technical documentation through CERs, post-market surveillance, and vigilance reporting.
View 51 DeliverablesIND · NDA/BLA · MAA · eCTD · ICH
Full-spectrum pharmaceutical writing from IND-enabling studies through NDA/BLA submissions, eCTD modules, clinical study reports, and post-approval safety reporting under ICH guidelines.
View 95 DeliverablesEU IVDR · FDA IVD · Performance Evaluation
Specialized IVD writing spanning IVDR technical documentation, analytical validation, performance evaluation reports, scientific validity assessments, and post-market performance follow-up.
View 47 DeliverablesPRISMA · Cochrane · GRADE · Meta-Analysis
Rigorous evidence synthesis supporting regulatory submissions and clinical evaluations — including systematic reviews, meta-analyses, network meta-analyses, and HTA submissions.
View 45 DeliverablesKOL · HEOR · Value Dossiers · Manuscripts
Strategic medical communications and publication support — from manuscript writing and congress materials to KOL presentations, value dossiers, HEOR reports, and patient education.
View 71 Deliverables
