Regulatory writing
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.
Regulatory medical writing plays a large role across the life-cycle of a product or device. From generating clinical development plans and study protocols through the development of the Common Technical Document for NDA/MAA submission, regulatory medical writing is of key importance in developing and conveying the therapeutic value as supported by the patient data.
MedVal 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 MedVal can help you stay ahead of an ever-changing regulatory environment.
- Preclinical Reports and Summaries
- Pharmcokinetic, Pharmacodynamic Studies
- Toxicology Analysis
- ADME, Including Drug Interactions and Toxicokinetics
- INDs, IDEs, (FDA)
- ITAs
- CTAs
- 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 Reports (all phases)
- Patient Narratives
If you would like us to contact you for planning, assistance and delivery in this vital area, please fill out the form below: