Ensure data accuracy and uniformity while maintaining full regulatory compliance.
Clear, concise, and professional presentation of study findings is an important part of any development program. With a full complement of medical writing services, we can help you ensure accuracy and uniformity while maintaining full compliance with regulatory requirements and International Council for Harmonisation (ICH) or International Committee of Medical Journal Editors (ICMJE) guidelines.
Medical writing experience you can count on.
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INDs supported
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Clinical study reports written
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Medical Writer Certified (MCW) experts on staff
Count on our project management experience, regulatory expertise, and proven reputation to help you:
- Manage your clinical projects whether the therapeutic area be acute, chronic, rare, or other
- Submit 505(b)(2) generic pathway NDAs
- Defend submissions in front of global regulatory bodies, including FDA, EMA, Health Canada, China FDA, and others
- Manage your entire compound pipeline
- Gap fill support where needed
- Streamline and improve messaging with our dedicated QC team comprised of trained reviewers and editors
- Rescue projects to get back on track
- Provide submission-ready documents with complete electronic formatting and internal linking
