Nitrosamine Risk Evaluation

The first deadline is approaching (March 31, 2021 for chemical medicines), make sure your company is meeting compliance standards. Choose Pharma D&S as service provider! #nitrosamine #riskevaluation #pharmadesgroup
March 25, 2021

Q&A: Good clinical practice (GCP)

EMA published a guidance in forms of Questions and Answers on good clinical practices. (GCP). Table of contents are:

  • Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials
  • GCP matters
  • Expectations of European Union (EU) competent authorities on the use of electronic trial master files
  • Records of study subject data relating to clinical trials

February 25, 2021