At MediPharm, we offer a full suite of pharmaceutical development and manufacturing services tailored to the EU regulatory environment, with a dedicated focus on sterile drug products in vial format. Our operations are fully compliant with EU GMP standards and EMA expectations, ensuring quality, consistency, and regulatory alignment throughout the product lifecycle.
Preparation of regulatory documentation in Common Technical Document (CTD) format, including Module 3 (Quality), in accordance with EMA and ICH guidelines. We support Marketing Authorisation Applications (MAA), post-approval variations, and Scientific Advice procedures.
Development, transfer, and validation of analytical methods in line with ICH Q2(R1), ensuring specificity, accuracy, precision, and robustness for batch release and stability testing.
Design and optimisation of manufacturing processes, scale-up from laboratory to commercial production, and execution of Process Validation (PV) activities in accordance with Annex 15 of the EU GMP Guide.
Structured and documented transfer of manufacturing and analytical procedures between development and production sites, ensuring reproducibility, traceability, and regulatory compliance.
End-to-end aseptic fill & finish operations for sterile liquid and lyophilised drug products in vial format. Conducted in EU GMP-certified Grade A/B cleanroom environments, with integrated visual inspection, labelling, secondary packaging, and Qualified Person (QP) release.
MediPharm a.s. operates as a pharmaceutical contract development and manufacturing organization (CDMO) based in Slovakia. The company specializes in the aseptic filling and lyophilization of sterile medicinal products, offering comprehensive services from technology transfer and clinical trial manufacturing to commercial batch production.
Focusing on small and medium-scale sterile manufacturing, MediPharm supports pharmaceutical partners in the development and production of injectable formulations, including niche products that require specialized handling and expertise. The company adheres to EU GMP standards and is regularly inspected by the State Institute for Drug Control (ŠÚKL).
Its infrastructure includes aseptic filling lines, freeze-drying units, and terminal sterilization capabilities, allowing for flexible production volumes and formats. In addition to manufacturing, MediPharm provides analytical testing, regulatory support, and stability studies to ensure product quality and compliance throughout the lifecycle.
Operations are governed by a robust pharmaceutical quality system in accordance with EU GMP, ICH, and ISO standards. Batch certification and release are performed by Qualified Persons (QPs), ensuring full regulatory compliance. Support is provided for audits, inspections, and pharmacovigilance activities, with strict adherence to data integrity and traceability requirements.
Stability programmes are designed and executed in line with ICH Q2(R2) guidelines, covering both long-term and accelerated conditions. Controlled storage environments and validated analytical methods support shelf-life determination and regulatory submissions.
Secondary packaging capabilities include labelling, tamper-evident sealing, and serialization compliant with the EU Falsified Medicines Directive (Directive 2011/62/EU). Aggregation and data exchange are enabled through validated systems, ensuring full traceability across the supply chain.
Projects are managed by dedicated cross-functional teams applying structured methodologies and defined KPIs. Transparent communication and proactive coordination ensure alignment with client objectives throughout development and manufacturing phases.
The manufacturing site is EU GMP-certified and equipped with Grade A/B cleanrooms, automated aseptic filling lines, lyophilisation units, and validated support systems. Environmental monitoring and equipment qualification protocols are maintained to ensure consistent product quality and inspection readiness.
A foundation built on regulatory competence, technical capability, and operational excellence supports a trusted CDMO partnership. Sterile medicinal product manufacturing is driven by flexibility, efficiency, and uncompromising quality standards.
Addres:
kpt. Nálepku 637/2, 082 71,
Lipany, Slovak republic.
Phone: +421 51/4880 222
Email: info@medi-pharm.sk