Before medicinal product release into the European Union market or before it’s administration to the patient during clinical trials, each batch of a given medicinal product needs to be certified by Qualified Person (QP) followed by drug release to the market process commonly known as a QP release (batch release).
In the case of the import of pharmaceutical product from a third country into the European Union, batch certification and release by QP are strictly required. Pharmaceutical product distribution to customers in each country is performed in accordance with local relevant requirements, however, it is always obligatory for QP batch release on the EU territory to be performed prior to transportation. At SciencePharma we provide QP services veryfing th quality medicinal products, manufacturing compliance with Good Manufacturing Practice (GMP) and compliance with documentation approved by the Competent Healthcare Authorities.
At SciencePharma we provide importation and supply chain managment services in field of:
In the European Union, every batch of medicinal products and investigational medicinal products must undergo certification and release by a Qualified Person (QP). At SciencePharma we offer medicinal products release service for:
SciencePharma we possess the higly specialized experta in batch certification and release of medicinal products and investigational medicinal products, ensuring that they meet high quality standards and comply with EU GMP and marketing authorizations. Our experts have extensive experience in handling both local and international products. SciencePharma also collaborates with audited contract laboratories for analytical batch release studies, minimizing potential quality issues. They cover a wide range of pharmaceutical forms, including sterile products.