QP Service / Importer
QP release and import of pharmaceutical product
Before medicinal product release into the European Union market or before its 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 the quality medicinal products, manufacturing compliance with Good Manufacturing Practice (GMP) and compliance with documentation approved by the Competent Healthcare Authorities. Trust the QP service provided by SciencePharma.
Import and supply chain management
At SciencePharma we provide importation and supply chain managment services in field of:
- improving the efficiency of the supply chain to save time and reduce costs,
- collaborating with trustworthy shipping companies for transportation,
- evaluating storage conditions to ensure proper handling of products,
- working with Custom Agencies to facilitate smooth customs clearance,
- organizing and managing warehouses effectively,
- overseeing quality control studies to ensure compliance with standards.
Medicinal products release
In the EU, every batch of medicinal products and investigational medicinal products must undergo certification and release by a Qualified Person. At SciencePharma we offer medicinal products release service for:
- medicinal products (MPs) intended for the market,
- investigational medicinal products (IMPs) intended for the use in clinical studies.
In SciencePharma, we possess the higly specialized expert 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.