Our Offer
Services
Our services are built on many years of practical experience in developing and manufacturing advanced therapy medicinal products (ATMPs). Unlike traditional consultancy firms, we perform these activities ourselves — which means our guidance is based on real-world expertise and proven practice.
How We Can Help
What We Do
Tissue Establishment Services
- Assistance with establishing collection and tissue establishments
- Tissue collection authorized by the national competent authority
- Validated transport of human tissues and cells at 2–8 °C
- Release of tissues collected at approved collection establishments
GMP Consulting
- Support with the implementation of aseptic manufacturing and validation of production processes
- Establishment and optimization of quality systems, including documentation development
- Auditing of existing GMP processes, gap analysis, and planning of corrective actions
- Preparation for external audits and certifications
GMP Quality Control
- Sterility testing – by direct inoculation according to the current Pharmacopoeia (2.6.1, 2.6.27), with the option of alternative testing using the Bact/ALERT system, including full validation
- Cleanroom monitoring – particle monitoring (APC M3) and microbiological monitoring using both active (Aeroscope MAS 110) and passive methods (settle plates, contact plates, and swabs)
- Cell phenotyping – by flow cytometry
- Mycoplasma detection – by quantitative PCR according to the current Pharmacopoeia (2.6.7)
Contract Development & Manufacture of ATMPs for Clinical Trials
- Development of ATMPs under GMP
- Manufacture of validation batches
- Preparation of IMPD (Investigational Medicinal Product Dossier)
GCP Consulting and Conduct of Clinical Trials
- Medicinal Products (EU Regulation 536/2014):
- Clinical trial design including statistical analysis plan
- Preparation of clinical trial application and CTIS entry
- Monitoring and regular safety reporting (DSUR, etc.)
- Pharmacovigilance oversight
- Data analysis, final report preparation, and publication support
- In Vitro Diagnostic Medical Devices (EU regulation 2017/746):
- Design of pre- and post-marketing clinical performance studies
- Preparation of trial documents, communication with Ethics Committees and SUKL (where applicable)
- Monitoring and annual reporting
- Vigilance
- Data analysis, final report preparation, and publication support
- Medicinal Products (EU Regulation 536/2014):
Specialized Services
- Specific cell expression profiling by quantitative PCR
- Biocompatibility testing of materials on various cell types (impact on cell viability, proliferation capacity, and phenotype stability)
- Antimicrobial activity testing of materials (including nanomaterials) against bacteria, yeasts, and fungi
