To ensure the healthy growth of the pharmaceutical market, while encouraging innovation and research, the US Food and Drug Administration (FDA) has developed a series of comprehensive measures and management tools. In IND application or NDA submission, you need to submit persuasive statistics including chemistry, manufacturing and controls (CMC) data, non-clinical pharmacology and toxicology data, human pharmacokinetics and bioavailability data, microbiological data, clinical data, safety data update reports, statistical data, case reports, related patents, samples, packaging and labels.
On the other hand, researchers use statistical analysis results to understand their findings. These results can answer the questions we concern most, such as whether or not a variable has an effect, whether these variables are related, or whether observations of different groups are the same or significantly different. Your results can be presented objective with the statistics substantiation.
Our ServicesStatistical Sections for Regulatory
Our statistical experts will help you to solve the statistical problems involved in the NDA submission process, as well as the statistical section of the Integrated Safety Summary (ISS) and Comprehensive Effectiveness Summary (ISE).
We provide exploratory data analysis for publications, abstracts, and marketing for our clients. We engage to help our clients to understand and gain insights into the data for publication and abstract writing marketing through our professional and reader-friendly exploratory data analysis. Our service can help our clients to interpret the data and recognize patterns without dealing with the difficult raw data.
We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee you cost-effective, complete and concise reports.
If you are unable to find the specific service you are looking for, please feel free to contact us.