Medical Writing
We provide medical document writing, structural organisation and consistency review. The client is responsible for signing and submitting documents.
For regulatory submission requests, we confirm engagement boundaries before quoting. The scope below is divided into Can take on, Recommended as a joint engagement and Not taken on.
01Medical Writing
Can take on: 5 items; Recommended as a joint engagement: 5 items; Not taken on: 3 items.
Written to the structure of chapters 1–16 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3.
Annual updates and incorporation of safety information based on an existing version.
Clinical summaries organised to the structural requirements of ICH M4E(R2).
Writing and compiling meeting application materials; attendance by our staff is not included.
Writing based on study reports and data supplied by the client, without conducting additional experiments; nonclinical study reports are reviewed and signed by the study director at the research institution.
Completed jointly with the client's regulatory or medical department, or a partner with a comparable track record.
Requires critical analysis of the overall clinical development programme; joint engagement is recommended.
Requires synthesis of nonclinical and early clinical materials into an overall assessment; joint work with the client's nonclinical and medical departments is recommended.
Requires an overall critical analysis of nonclinical studies; a joint engagement is recommended.
Responses have tight deadlines and must align with the overall submission strategy; joint work with the client's regulatory department or a partner with relevant experience is recommended.
Outside the scope of this writing service.
Our professionals all work overseas; we do not undertake these activities.
We do not conduct experimental (laboratory or animal) studies. GLP compliance responsibility rests with the research institution.
02Medical Writing
For a first engagement, we recommend starting with one document or chapter, reviewed and signed by the client's regulatory or medical department.
We may also undertake the writing component as a consortium member or subcontractor to the lead contract research organisation (CRO). We do not act as the entity responsible for the regulatory application.
Article nine of the Measures for the Administration of Drug Registration (药品注册管理办法) (State Administration for Market Regulation Order No. 27, 2020) requires the applicant to be an enterprise or drug development institution able to assume the relevant legal responsibilities. We undertake the agreed document work; the client is responsible for signing and submission.
ICH E6(R3), Annex 1, section 3.6.6 allows sponsors to transfer trial-related activities in accordance with applicable regulatory requirements, while retaining ultimate responsibility for their trial-related activities. Our contracts follow this allocation.
Article forty-five of the Measures for the Administration of Drug Registration (药品注册管理办法) provides for extended inspections of other entrusted institutions where necessary. We deliver evidence traceability tables and quality control logs, retaining the source and verification date for each claim.
03Medical Writing
We write the agreed periodic reports and safety documents. We do not collect, assess or submit individual case safety reports, or act as the entity responsible for pharmacovigilance.
We can deliver working health economic model files in Excel or R, as specified by the client, and write the economic sections of a value dossier.
We undertake clinical evaluation reports (CER), post-market clinical follow-up (PMCF) documents and clinical evaluation materials for registration in China. CER evaluators are appointed by the client and sign the evaluation report; we conduct evidence searches, appraisal and writing.
These specialist materials do not change the regulatory submission engagement status listed on this page. The client remains responsible for signing and submitting documents.
04Medical Writing
Regulatory submissions are a service area we are developing. We do not yet have a prior track record that we can cite publicly for NMPA regulatory submission projects.
If a project requires suppliers to provide a comparable regulatory submission track record, the client should state this when requesting a quotation. Team academic roles, records of other services and public research examples do not substitute for that track record.
A first engagement may be limited to one document or chapter. Further collaboration can be agreed after the first round, once both parties have established how they will work together.
05Medical Writing
Please provide document types, the current stage, deadlines and the status of available materials, and state whether joint engagement, supplier onboarding documents or a comparable regulatory submission track record are required. We confirm engagement boundaries before issuing a requirement confirmation form and itemised quotation.
Shows the chapter organisation of a CSR for comparison with the document structure.
Get started · Submit a request
Please provide the document type, quantity, project stage, intended use, available materials and deadline requirements. We first issue a requirement confirmation form, followed by an itemised quote and schedule.
This section describes our services. It does not concern any specific medicinal product and does not constitute drug advertising. The timelines, quality control and issue resolution processes described are our standard operating approach; the final scope, timelines, prices and obligations of each party are governed by the signed contract.
Our contribution is disclosed in the acknowledgements in line with ICMJE and GPP 2022; we are not listed as authors. For writing and statistical support for research publications, involvement and funding sources are disclosed truthfully under the International Committee of Medical Journal Editors recommendations and Good Publication Practice 2022. We do not promise publication outcomes.
