Regulatory Writing Services
Expert regulatory writers, backed by AI-assisted tools that generate submission ready documents in record times.
At QInscribe, we understand that well-crafted regulatory documents are critical to the success of clinical development programs and regulatory submissions. Our Regulatory Writing Services uses cutting-edge AI technology to generate regulatory documents that bring market leading speeds to the medical writing industry. Are services are designed to support pharmaceutical, biotechnology, and medical device companies in preparing clear, accurate, and compliant documentation that meets the requirements of global regulatory authorities, including the FDA, EMA, MHRA, PMDA, and others.
Our AI-driven approach brings efficiencies , accelerates submission timelines, and positions your organisation confidently for success at every stage of the regulatory approval process.
Our AI Powered Process to Regulatory Writing
- Cost-effective automation for early drafts: Our AI-assisted reporting engine can generate drafts and templates quickly to ease the editing process for our writing team, minimising cost and maximising your team’s mobility.
- Expert regulatory writer review: Upon completion of the first draft AI generated document, our experienced regulatory writers review and make any necessary edits to move the document on to completion
- Final QC: We understand there may be hesitancy in AI solutions with stories of hallucinations and errors, that’s why our entire first draft document generation has been fully QC’d and validated, but in addition, all our regulatory documents go through a stringent, human led QC process to ensure 100% quality.
Our Regulatory Writing Services Include
Clinical Study Reports
Developed in accordance with ICH E3 and other global standards, our AI-powered CSRs are scientifically robust, well-structured, created in industry record times and submission-ready. Whether for Phase I or pivotal Phase III/IV studies, our AI approach can handle any type of CSR from any phase of therapeutic area. Read more.
Informed Consent Documents
Clear, compliant, and ethically sound informed consent documents to protect patients and facilitate regulatory and ethical approvals. Read more.
Standalone QC
Independent, thorough QC review of all types of documents to ensure regulatory documentation is accurate, consistent, and compliant before submission. Read more.
Patient Safety Narratives
We offer an automated approach to the generation of Patient Safety Narratives. We offer complete support in the compilation, formatting, quality control, and publishing of narratives ensuring alignment with submission standards and seamless integration into regulatory dossiers. Read more.
CTD Module 2 Summaries
We provide expert authoring support for Common Technical Document (CTD) components, including the Clinical Overview (module 2.5), Clinical Summary (module 2.7) and associated appendices clearly communicating critical data to global regulatory authorities. Read more.
Clinical Study Protocol & Protocol Amendments
Robust, compliant clinical trial protocols designed to minimise amendments, with a focus on scientific rigor, tailored for regulatory and operational clarity and streamline regulatory approvals. Read more.
What You Gain by Partnering with QInscribe
Reduced Costs
Our AI tools, automation, and programmatic approach allows us to streamline the first draft of many regulatory and medical documents. With fewer hours required to complete documents, we guarantee competitive industry rates and cost savings.
Proven Expertise
Our team comprises seasoned regulatory writers and scientists with extensive experience across therapeutic areas and document types.
Compliance Assurance
Every document we produce strictly adheres to international regulatory standards (FDA, EMA, ICH-GCP guidelines).
Strategic Partnership
We align writing outputs with your clinical and regulatory goals, accelerating timelines and strengthening your submission strategy.
Operational Efficiency
Our structured processes and templates streamline document production, saving your team time and resources.
Built on Trust
We clearly communicate complex scientific data, facilitating efficient regulatory review and approval.
Let’s help you move forward, faster and with fewer hurdles
Partner with QInscribe for AI-powered regulatory writing services to drive your clinical programs confidently toward global regulatory success.