Cliniserve offers services of Clinical Summary & Non Clinical Summary writing for all regulatory submission. We deliver accurate, timely with highest ethical and scientific standards.
Importance of Regulatory Writing
The importance of preparing high-quality regulatory documents is often under estimated. Clinical Summary & Non Clinical Summary are the final result of many months of hard work by various stakeholder and to summarise the conduct and results of a clinical study in a clear and unbiased manner.
In the ever-changing regulatory environment, experienced regulatory writers can add a lot of value to the production of regulatory submission documentation.
Regulatory writers are skilled at meeting global regulatory requirements and adhering to guidance documents such as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP).