Scientific Writing
Whether it is a clinical site interpreting a protocol, a peer reviewer deciding whether your manuscript should be accepted into a prestigious journal, or a regulatory agency reviewing your IND, it is important that your message is conveyed in a way that is clear, impactful, and appropriately written for your target audience.
Nuventra’s consultants bring to bear many years of scientific, medical, and regulatory writing experience to meet our clients’ needs. Our consultants have experience authoring a diverse array of documents for submission to the FDA and other regulatory agencies, as well as scientific manuscripts for submission to peer-reviewed journals.
In addition to the experience of our consultants, Nuventra has critical infrastructure in place to ensure that the documents we deliver to our clients are of the highest caliber. We have robust document templates and medical writing SOPs coupled with a rigorous quality control (QC) process to allow for production of high quality, submission-ready documents.
Scientific Writing Services
- Biologics License Application (BLA)
- Clinical pharmacology study protocol
- Clinical study report (CSR)
- Fast Track, Breakthrough Therapy, Priority Review, Regenerative Medicine Advanced Therapy (RMAT) Applications
- FDA meeting request and briefing package
- Informed Consents and Assents
- Integrated Summaries of Efficacy (ISE)
- Integrated Summaries of Safety (ISS)
- Interim Data Summaries
- Investigational New Drug (IND) Application
- Investigator Brochures
- Medical manuscript or journal article
- New Drug Application (NDA)
- Orphan drug application
- Pediatric Study Plan (PSP)
- Pharmacokinetics/pharmacodynamics (PK/PD), toxicokinetics (TK), and population PK reports
- Product Development Plans
- Safety Narratives
- Safety Update Reports
