We are your end-to-end regulatory writing solution, with the expertise and resources to provide writing services from preclinical through all phases of clinical research and registration, as well as post-approval.
PharmaWrite can help prepare these critical documents and, with our experience in conducting regulatory meetings, provide meeting preparation and logistical support.
Our writers will collaborate with your team or manage the document development process to ensure compliance with regulatory guidance and industry best practices.
Download our informational fact sheet to learn how PharmaWrite can help you stay ahead of an ever-changing regulatory environment.
- Preclinical reports and summaries
- Pharmcokinetic, pharmacodynamic and toxicology analysis
- ADME, including drug interactions and toxicokinetics
- INDs, IDEs (FDA)
- ITAs (Devices for Health Canada)
- CTAs (EU and Health Canada)
- Investigators' Brochures (including preclinical and CMC sections)
- Protocols
- Literature reviews
- Posting to clinical trials registry
- Informed consent documents
- Investigational product labels
- Clinical safety and efficacy study reports (all phases)
- Patient narratives
To learn more about how PharmaWrite can assist your company, please contact us here.