Medical Writing
OUR TEAM’S EXPERTISE
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We offer medical writing services in a wide range of therapeutic areas performed by experienced medical writers with PhDs in life science and over ten years of experience. These include study-specific documents and development-program documents.
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The medical writing service is integrated into multi-disciplinary clinical development teams.
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Our scientific-minded writing team has significant experience preparing clinical documents.
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We excel in developing regulatory documents to support drug, device, and diagnostic marketing submissions to regulatory agencies.
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We understand the complexities of writing in a highly regulated environment and the requirements of regulatory agencies.
HOW WE HELP CLIENTS
Medical Writing for Clinical Trials & Regulatory Submissions
We provide medical writing support for the entire life cycle of a product’s development. We offer rapid turnaround to meet tight timelines and efficient processes. We apply best practices to meet technical and regulatory requirements. Our expert medical writing team supports the development of the following types of documentation:
Clinical trial and program documentation
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Protocol synopsis, protocols, and amendments
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Informed consent forms
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Clinical study reports (CSRs)
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Safety narratives
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Clinical development plans
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Investigator brochure and patient information leaflets
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Annual reports
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Periodic safety update reports (PSURs)
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Development safety update reports (DSURs)
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Periodic benefit-risk evaluation reports (PBRERs)
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Regulatory submission documents
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Marketing applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)
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Clinical & non-clinical summaries (Module 2)
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Integrated summaries of efficacy and safety (Module 5)
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Responses to agency reviewers
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Regulatory briefing documents for agency meetings, including:
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Pre-IND, end of phase 1, end of phase 2/3, pre-NDA and advisory committee
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Orphan drug designation applications
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Risk management plans
eCTD services
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Create and edit eCTD documents according to ICH and national regulatory authority guidelines.
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Manage documents and eCTD sequence lifecycles on a dedicated document management system.
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Create and publish eCTD sequences on a dedicated eCTD compilation system.
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Validate eCTD sequences using specialized validation tools.
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Submit eCTD sequences to regulatory agencies.