Documentation that Delivers
Effective medical writing is essential throughout the drug development lifecycle. From clinical study reports that support regulatory submissions to scientific publications that establish your product's place in medical practice, clear and accurate documentation directly impacts success.
RegOps medical writers combine scientific training with regulatory awareness and communication expertise. We understand that every document serves a purpose—whether informing regulatory decisions, guiding clinical practice, or advancing scientific knowledge. Our writing is accurate, appropriately detailed, and crafted to achieve your communication objectives while meeting stringent regulatory standards.
Our Capabilities
From protocols to publications.
Complete CSR authoring compliant with ICH E3. We develop full reports and synopses that accurately present study design and results for regulatory review.
Development of clear protocols that meet regulatory requirements and support operational execution. We ensure protocols are scientifically sound and feasible.
Authoring and maintenance of IBs that compile relevant information for investigators. We ensure content supports informed consent and safe study conduct.
Authoring support for briefing documents, clinical overviews (2.5), and summaries (2.7) that present your clinical program clearly to health authorities.
Development of manuscripts, abstracts, and posters for peer-reviewed publication. We ensure scientific accuracy and compliance with guidelines.
Plain-language ICF development that meets regulatory requirements and supports meaningful participant understanding of procedures and risks.
The RegOps Advantage
We combine therapeutic expertise with regulatory awareness to deliver high-quality documentation.
Therapeutic Expertise
Our writers have backgrounds in relevant therapeutic areas and can engage substantively with clinical and scientific content.
Regulatory Awareness
We write with the reviewer in mind, anticipating questions and ensuring documents address likely concerns proactively.
Timeline Focus
We understand the pace of clinical development. We deliver quality work within the timelines your program requires.
Collaborative
We work closely with clinical teams and statisticians to ensure our writing accurately reflects the data and your interpretation.