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.
Our Scientific Writing Services:
- Pharmacokinetics/pharmacodynamics (PK/PD), toxicokinetics (TK), and population PK reports
- Clinical pharmacology study protocol
- Clinical study report (CSR)
- Investigational New Drug (IND) Application
- New Drug Application (NDA)
- Biologics License Application (BLA)
- FDA meeting request and briefing package
- Orphan drug application
- Pediatric Study Plan (PSP)
- Medical manuscript or journal article