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
Calculator and office equipment on some paper at SCTbio offices in Prague.

Our Services

Cell and gene therapy researchers working in SCTbio’s GMP laboratory.
Lab technician working at a microplate reader in SCTbio’s cell and gene facility.
Lab employees in full personal protective equipment handling cell and gene therapy products.
Employee loading up a cardboard box of biologic samples at SCTbio’s contract manufacturing facility.
Employee loading up a cardboard box of biologic samples at SCTbio’s contract manufacturing facility.
Calculator and office equipment on some paper at SCTbio offices in Prague.