The quality section of the Investigational Medicinal Product Dossier (IMPD) —which deals with the chemistry, manufacturing, and controls (CMC) of a drug— is a very critical factor to have a clinical...
Biotech and pharma companies planning clinical trials in Europe will have to submit a clinical trial application (CTA) to the national regulatory authorities of the countries in which the clinical...
Biotech and pharma companies conducting clinical trials in Europe —with a drug product (DP) manufactured in a non-EU country— will need a Qualified Person’s (QP) Declaration when submitting the...
Europe, together with the United States and Asia, is one of the regions in the world where more clinical trials are carried out. Currently in the US database Clinicaltrials.gov, there are 65,572...