Statistical disciplines

Introduction

Regulatory requirements for documentation of safety, performance and durability makes it essential for Life-science industries to develop and implement statistical methods that can ensure stability, capability and predictability of processes throughout the product lifecycle.

We have more than 25 years of experience in identifying, implementing,and teaching statistical methodsat all levels, ranging from basic data analysis to advanced statistical modelling.

Statistical Process Control (SPC)

Achieve stable, predictable and capable manufacturing processes by simple statistical tools.

Acceptance Sampling

Use statistical sampling to determine acceptability of production lots of raw materials and finished products.

Statistical Test and Analysis

Use statistical tests and analyses forevidence-based decision making during development and troubleshooting.

Design of Experiments

Optimize manufacturing processes and increase your process understanding

Sample Size Determination

Calculate statistically based sample sizes for Design Verification and Process Validation

Reliability/Durability Estimation

Employ predictive methods to predict and substantiate durability and shelf-life claims
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Pharma4ever A/S

Agervej 4, 4340 Tølløse

Denmark

info@pharma4ever.com
+45 42 70 20 90
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