CONSULTANCY
Expert guidance in biological material storage, logistics, and regulations.
Welcome to the Consultancy services at Biostór. With over 90 years of combined experience in the Life Science and Logistics industries, our founders Peadar Mac Gabhann and Uwe Kuhn lead our consultancy team. We are your trusted partners for comprehensive solutions in the storage, transportation, and regulation of biological materials.
YOUR TRUSTED CONSULTANCY PARTNER
At Biostór, our consultancy service is built on a foundation of best practices and industry standards in biological material storage and logistics. Whether you’re seeking guidance on process optimization, data management, regulatory compliance, or facility design, our expertise covers a wide range of areas.
EXPERT INSIGHTS AND PLANNING
Our consultancy team provides insights into:
Good Distribution Practices, auditing, and certification of transport providers.
Brexit’s impact on pharmaceutical product transport, import, and export.
IATA Dangerous Goods Regulations, CITES Convention compliance, UN3373, GMO, and WHO Transport Guidance.
Contingency planning, risk analysis, disaster recovery, and facility relocation projects.
COMPREHENSIVE SOLUTIONS
Our consultancy services encompass a spectrum of solutions tailored to your needs:
Process analysis, workflow optimization, and systems implementation, including data management strategies.
GDPR compliance, data encryption, sample pseudonymization, and real-time data visibility to ensure data security and privacy.
Inventory and sample management, barcode and RFID tracking, and sample repurposing strategies.
Biorepository and Bio-Storage facility design, encompassing cryogenic and liquid nitrogen storage, tissue and cell banking, and MCB development and storage.
Biopharmaceutical and cell therapy facility concept, design, and implementation, with equipment procurement and vendor analysis.
GMP compliance, quality management system development, and clinical trial sample storage.
Cold chain logistics, supply chain reliability, packaging optimization, and temperature-controlled distribution.
Regulatory affairs guidance, covering EU Tissues and Cells Directives, GDPR, Clinical Trials Regulations, and more.
REGULATORY CONSULTANCY
Our Regulatory Affairs Services support your Human Cells and Tissue Products to get approval into the EU market with regulatory, scientific advisory support by our Licenced Tissue Establishment:
We can support you in submitting an HPRA Application: our experts can advise, plan, and deliver a smarter strategy to ensure your products are available to patients around the world, whether you’re a US-based biotech trying to reach specific or all markets, or a more established European company in need of assistance.
We keep you up to date on regulations and requirements, how policies are evolving and help you plan for new requirements and updates, assisting submissions/approval processes.
Biostór has successfully managed a diverse range of regulatory projects for the application of various tissue products for human application including, but not limited to:
GUIDANCE FOR THE FUTURE
Trust Biostór’s experts to offer guidance on cloud-based storage and to navigate the complexities of regulatory affairs in the ever-evolving landscape of the life sciences and logistics industries.
