Our Services
Aroga offers a true “one-stop-shop” experience: from medical writing to QC to eCTD publishing, our integrated workflow ensures accuracy, efficiency, and on-time delivery.
Aroga offers a true “one-stop-shop” experience: from medical writing to QC to eCTD publishing, our integrated workflow ensures accuracy, efficiency, and on-time delivery.
Medical Writing Services
Expert Medical Writing for Regulatory, Clinical, and Scientific Documents
Aroga delivers high-quality, compliant, and scientifically accurate medical writing services that support your programs from early development through regulatory submission. Our team of advanced-degree scientists and experienced writers specialize in creating clear, consistent, and submission-ready documents aligned with ICH and regional guidelines.
Clinical Writing
We provide comprehensive clinical writing services to support every stage of drug development.
Deliverables include: Clinical Study Reports (CSRs), Protocols, Investigator’s Brochures, Clinical Trial Applications, Development Plans, and CTD Summaries.
Our writers ensure clinical narratives and results are presented with accuracy, consistency, and scientific integrity—ready for internal review or agency submission.
Regulatory Writing
Aroga’s regulatory writers bring precision and strategy to every submission.
Deliverables include: INDs, NDAs/BLAs, Regulatory Responses, Briefing Packages, Pediatric and Orphan Drug Plans.
We partner with sponsors to streamline submissions and ensure alignment with FDA, EMA, and ICH expectations—helping you communicate your science effectively and meet critical milestones.
Safety Writing
Our safety writing experts specialize in authoring and updating safety-related documents that comply with global pharmacovigilance standards.
Deliverables include: DSURs, PSURs, Risk Management Plans (RMPs), and Safety Updates.
We ensure accurate data presentation, consistency across reports, and timely delivery to support ongoing product safety surveillance.
CMC Writing (Chemistry, Manufacturing, and Controls)
Our CMC writers prepare technically sound and regulatory-compliant documentation to support manufacturing and product lifecycle needs.
Deliverables include: CMC Summaries, Technical Reports, and Investigational Medicinal Product Dossiers (IMPDs).
We ensure that all CMC information is logically presented, consistent, and ready for regulatory review.
Non-Clinical Writing
Aroga’s team provides expert support for non-clinical documentation with clear data interpretation and alignment with regulatory expectations.
Deliverables include: Study Overviews, Non-Clinical Summaries, IDonnvestigator’s Brochures, and Toxicology Study Reports.
Our non-clinical writers bridge the gap between raw study data and regulatory-ready narratives.
Publication Writing
Aroga Biosciences offers full-service publication writing support, including manuscripts, abstracts, posters, and scientific presentations. Our writers combine scientific expertise with publication strategy to help clients communicate their research with precision and impact. Deliverables include:
- Manuscripts – From outline to submission, including journal selection and author coordination.
- Abstracts – Concise, data-driven abstracts aligned with conference requirements.
- Posters – Visually engaging and scientifically accurate materials for effective presentation.
- Presentations – Slide decks and speaker notes designed for clear, confident delivery.
Our publication team ensures every deliverable reflects accuracy, consistency, and compliance with international publication and authorship standards—helping your data make an impact in the scientific community.
Quality Control (QC)
Rigorous Quality Control for Accuracy and Compliance
Our QC team ensures every deliverable is scientifically sound, consistent, and submission-ready. Using a structured, data-driven approach, we verify content accuracy, formatting, and adherence to style guides.
We perform:
- Data Verification: Cross-checking against statistical outputs (tables, listings, and figures).
- Editorial Review: Ensuring consistency in language, tone, and terminology across documents.
- Regulatory Readiness: Confirming documents meet publishing and agency requirements.
Every QC professional at Aroga has an advanced scientific background, ensuring your documents are reviewed not just for grammar—but for scientific and data integrity.
Quality Assurance (QA)
Integrated Quality Assurance Oversight
Aroga’s QA team provides independent oversight to maintain compliance, consistency, and inspection readiness across all regulated activities.
Our QA services include:
- Quality System and SOP Governance aligned with ICH, FDA, EMA, and ISO 9001 standards
- CAPA and Audit Management to support continuous improvement
- Vendor Oversight and Document Control ensuring end-to-end compliance
- Embedded QA in Full-Service Workflows—ensuring quality standards from document creation through submission
Our proactive QA model fosters compliance without slowing operations, giving clients confidence that every process meets the highest regulatory expectations.
Regulatory Operations
Regulatory Publishing and Submission Excellence
Aroga’s Regulatory Operations team provides complete document publishing and submission management services to ensure your dossiers are formatted, validated, and compliant for electronic submission.
Document-Level Publishing
We ensure all documents are properly formatted, hyperlinked, and bookmarked for submission readiness. Our experts maintain consistency across modules and ensure agency-compliant publishing standards.
Regulatory Submissions
End-to-end eCTD submission support—from content preparation and document QC through final publishing and submission to health authorities.
We manage timelines, coordinate deliverables, and ensure seamless communication across all contributors.
Project Management
Strategic Project Management for Seamless Execution
Aroga’s Project Management team not only ensures seamless execution but also drives timeline creation, development, and proactive monitoring across all deliverables. Our PMs collaborate closely with clients and internal teams to establish realistic schedules and keep every milestone on track—especially valuable for smaller organizations without dedicated planning infrastructure.Our project management services include:
- Strategic Planning and Timeline Management to anticipate risks and maintain milestones
- Cross-Functional Coordination ensuring smooth communication and workflow efficiency
- Proactive Issue Resolution through real-time monitoring and solution-driven planning
- End-to-End Ownership from initiation to submission, eliminating gaps and handoffs