- Consultancy
Strategy and procedures
- Services
- Solutions
Dossplorer regulatory dossier viewer
Submission document templates and content plan
- Customers & Cases
Submission document authoring
Concise, compliant and submission-ready documents
Faster review and assessments by unambiguous submission document authoring
Qdossier writers have the skill set to provide the information in an unambiguous way; meaning that factual information will often be provided in tabular formats and bullet lists, rather than narratives. On the contrary, scientific evaluations will be in narratives and focus on unexpected results, rather than summarizing the obvious ones. As a result, the submission document authoring will be concise, resulting in faster review and internal approval. It also helps the assessors to quickly navigate through the dossier, allowing swift and proper assessment.
When authoring submission documents, our writers use the MS-Word features to allow for right-first-time formatting of the document. Together with the Qdossier eCTD templates, these facilitate eCTD-ready PDF files upon rendering. Therefore, post-finalization publishing, which is always on the critical path, is limited to a minimum.
‘I did not have time to write you a short letter, so I wrote you a long one’.
Quote Mark Twain
Your best partner in preparing right-first-time documents
Our document preparation services include proofreading, logic checks, review of draft documents, and initial drafting of regulatory documents. We prepare your documents using our well-structured eCTD templates and style guide. We help our customers achieve the highest quality with regard to scientific content as well as formatting and style. We are committed to providing you with comprehensive, concise, and clean regulatory documents in compliance with the standards and expectations of health authorities. Qdossier experts have an in-depth understanding of each document’s requirements based on the submission type and product.
How we can support you
Qdossier team can provide you the support for the following regulatory documentation:
1. Clinical study reports (CSRs)
2. Clinical protocols
3. Investigator Brochure, Environmental analysis, and General Investigation Plan for initial IND using in-house Dosscriber templates
4. Components of Investigational New Drug (IND) applications
5. Paediatric investigation plans (PIPs)
6. Review of Scientific advice (SA) for CMC and clinical part
7. Review of briefing books
8. Assistance in preparation of pre-IND meetings
Your best partner in preparing right-first-time documents
Qdossier has developed document templates supporting lean authoring, by providing tabular format templates for presenting factual information for easy interpretation.
Support for both emerging and established pharmaceutical companies in defining and executing regulatory strategic activities.
The content plan enables authors to apply the best document granularity and to harmonize authoring-, naming-, cross-referencing- and archiving practices.