Quality and Regulatory Support
& Qualified Person Services

Well established quality system in place, all services related with release of final drug products within EU, UK and US.

• Quality system in line with requirements from different territories (US, EU, China, Japan, Australia)
• Flexible overall GMP training and project specific training
• Quality Representative (single contact with backup) for Quality related tasks
• Readiness to support Client in different areas (technology transfer, supplier and material evaluation, regulatory submissions, region-related specifics)
• Mature documentation system in place
• On-site audit readiness 
• Transparent Quality System – Quality Management Review, Quality Events trending.
• Electronic Quality Systems and Quality Document Management platform in place (Veeva)
  • Segregated virtual space for products / projects related content 
  • Sharing and approval of project specific documents with clients
• ATMP specialized Qualified Persons and auditing
• Quality Management System design, implementation, monitoring and evaluation

• Regulatory authority interactions (e.g. EMA, FDA, VHP procedure, Scientific advice meetings, Orphan drug designation process)
• CMC (IMPD Module 3) preparation and review
• Stability study design
• National cells and tissue legal framework advise
• EU GMO approvals
• Support of international cooperation network of qualified and regularly monitored
  cell-collection sites
• Laboratory computer systems validation

Our Services