We can help you to report or summarise medical data into clear and readable texts in accordance with scientific principles and regulatory requirements.
We provide a wide variety of documents and reports throughout the life cycle of a pharmaceutical or medical device. Our skilled team members have previous experience from product development, clinical trials, and academia.
Let us assist you with :
- Investigator’s Brochure (IB)
- Investigational Medicinal Product Dossier (IMPD)
- Periodic safety report (DSUR)
- Study report
- Study protocol
- Environmental risk assessment (ERA)
- Risk management plan (RMP)
- Nonclinical summary and overview
- Clinical summary and overview
- Periodic Benefit-Risk Evaluation Report (PBRER) Manuscripts
- Literature summaries