Medical Writing
Expert Medical Documentation You Can Trust
Medical writing demands precision, clinical accuracy, and regulatory knowledge. At Qinecsa, we deliver exceptional medical writing services across the drug, devices and combination products’ landscape, ensuring your documentation meets the highest standards of clarity, compliance, and scientific integrity. Our expert team of scientists and physicians have extensive experience in developing accurate and thorough reports for commercial and clinical products.
We also specialise in synthesising clinical evidence to support the safety profiles of your products. From systematic literature reviews to benefit risk reports, our writers transform research findings into robuts documentation that demonstrates the safety, performance, and clinical benefits of your products.
When you partner with Qinecsa, you gain access to a team of professionals that understands both the clinical space and post-marketing environment. Our collaborative approach begins with a thorough understanding of your specific requirements, audience, and strategic objectives and Qinecsa provides the expertise and reliability you require.
Regulatory Submission Support
Navigating regulatory requirements requires specialised knowledge and attention to detail. Our team is here to assist with regulatory submissions and develop documentation that aligns with requirements across multiple jurisdictions, including the UK, EU, and US. We ensure your submissions are thorough, accurate, and strategically framed to support successful regulatory outcomes.
We also specialise in synthesising clinical evidence to support the safety profiles of your products. From systematic literature reviews to clinical evaluation reports, our writers transform research findings into succinct documentation that demonstrates the safety, performance, and clinical benefits of your medical devices.
Case data often contains complex relationships between products, documents, communications, events, and actions. These interconnected features create migration challenges that generic approaches may not adequately address:
Our scientists and physicians generate expert reports to support regulatory submissions across the development lifecycle.
Succinct Conclusions
Generate and maintain an accurate reflection of safety profiles across multiple data sources.
Ensure Compliance
Seamlessly incorporate both internal requirements and regulatory commitments into reports.
Manage Multiple Stakeholders
Ensure all stakeholders are clear on roles and responsibilities early in the process to streamline submission.
Unrivalled Medical Writing Services
Aggregate Reports
- Aggregate reporting with expert support.
- Experienced scientists and physicians writing.
- Benefit-risk management guarantees safety.
- Regulatory team ensures global readiness.
Protocol Review
- Global protocol review with expert support.
- Management, review, and scheduling.
- Expertise in protocol design and planning.
- Expert collaboration ensures resource optimization.
Risk Management Reports
- RMP preparation and submission formats supported
- Risk identification and management.
- REMS include goals and required activities.
- Version-controlled RMPs provided as single PDF.
Experienced Drug Safety Writers
- End-to-end medical writing lifecycle management.
- Agile teams across all ICH regions.
- Technology-enabled report management.
- Collaborative global stakeholder management.
Working with Qinecsa for Your Medical Writing Needs
When you partner with Qinecsa, you gain access to a team of professionals that understands both the clinical space and the regulatory environment. Our collaborative approach begins with a thorough understanding of your specific requirements, audience, and strategic objectives. Whether you need support with a critical regulatory submission, educational materials, or ongoing documentation maintenance, Qinecsa provides the expertise and reliability you require.
