CONSULTANCY

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. 

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.

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.