Import/ QP batch release

QP Batch certification of IMPs (Investigational medicinal Products)

Product Category for QP batch release

Small molecules
Sterile medicinal products
Biologicals
Vaccines
ATMPs (Advanced Therapy Medicinal Products) such as gene therapy & somatic cell therapy medicinal products
APIs (human, animal or microbial origin or manufactured using genetic engineering)

Type of QP batch certification for above itemized Product Category for QP batch release

QP import certification to release IMPs imported from 3rd countries into the EU
QP export certification to release IMPs for export from the EU to 3rd countries
QP batch certification to release IMPs within the EU

Consultancy Service linked to QP certification

GMP/ Quality development from clinical trial phase I to II to III
Content of Investigational Medicinal Product Dossier (IMPD)
Compilation of Product Specification File (PSF)
Supply Chain Qualification
Changes: non-substantial vs substantial modifications
Interface between GCP and GMP
Packaging and Labelling incl. blinding
EU legislation
Quality Technical Agreements (QTAs)
Others