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.

We can offer

  • 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 support

  • 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