We have highly experienced medical writers who can support you in the preparation of regulatory documents that meet the expectations of regulatory authorities. We are specialists in summarizing and presenting complex scientific information in a clear, correct, and transparent way.
We have a thorough understanding of scientific and regulatory requirements and look at your development program from a holistic perspective where each document plays a part in the overall messaging. By supporting data interpretation and suggesting improvements in communicating your messages to your target audiences, we can facilitate your drug development at all stages We always tailor our writing services to meet your requirements.
We offer the creation of all regulatory documents like:
- Clinical study protocols and reports
- Investigator brochures
- Publications
- Documents for:
- Marketing application
- Non-clinical and clinical summaries
- Clinical overviews
- Risk management plans
- Product information documents
As experienced medical writers we are an integral part of many project teams, working, collaborating closely with our clients and internal experts to reach our common goal: the seamless development and timely approval of high-quality drugs.
