Statistical planning
Support with study design, estimands, analysis planning and statistical methods. Focusing on Regulatory acceptability.
Regulatory Statistics for Pharma and Biotech
Specialist statistical support for regulatory interactions.
Semita helps drug development companies prepare for regulatory interactions, with specialist support in statistics, study design, and regulatory acceptability.
View services Contact SemitaHow Semita can help
- During protocol development
- Preparing for regulatory interactions
- Assessing the CSR prior to MAA
- Support answering questions from regulators
What we help with
Practical statistical and regulatory support tailored to your project.
Regulatory interactions
Review of documents, anticipation of questions and support preparing answers. Attending meetings with regulatory authorities if needed.
Submission support
Review of submission documents, highlighting any potential issues with regards to statistics and/or study design.
Who we support
We work with health, research, pharmaceutical, biotechnology and consultancy organisations that need rigorous statistical or regulatory input.
Why work with us
We bridge the gap between sponsor objectives and regulatory expectations, leveraging our expertise to identify a clear path that is acceptable to both.
Start a conversation
Get in touch to discuss how statistical or regulatory support could help your project.
Email us