Regulatory submissions are an important part of any clinical trial. Ensuring that your submissions meet a high-quality standard can help to accelerate the time it takes to get your trial approved. The regulatory requirements also differ depending on the type of clinical trial being conducted.
dicentra’s interdisciplinary clinical team has combined experience in regulatory affairs, data management, medical writing, project management, and biostatistics, ensuring that every regulatory submission meets the highest standard possible, while being specifically tailored to your trial’s needs.
Our Services Include Support With:
- Protocol Design & Development
- Protocol Review
- Informed Consent Documentation
- Preparation of electronic Common Technical Documents
- Clinical Trial Applications
- Clinical Trial Application Amendments
- Clinical Trial Application Notification
- Clinical Trial Site Information Forms
- Quality Overall Summary/Quality Information Summary
- New Drug Submissions
- New Drug Authorizations
- Supplement to a New Drug Submission
- Drug Identification Number
Contact us for assistance with your regulatory submissions.