QP Batch Release, Quality, and Regulatory Support
A well-established GxP-compliant quality system supporting the release of final drug products across the EU, UK, and US. We manage all regulatory and documentation requirements to ensure agile, compliant product release — giving you confidence in every batch.
Global Quality System
Quality system aligned with regulatory requirements across the EU, US, China, Japan, and Australia
Mature documentation system and electronic quality platform (Veeva) with segregated virtual spaces for each project
Transparent quality oversight through Quality Management Reviews and trending of quality events
Benefit:
You gain a globally recognized, audit-ready quality framework that supports your product’s success in multiple markets.
Client-Centric Quality Support
Dedicated Quality Representative with backup for consistent communication
Flexible GMP training programs, including project-specific modules
On-site audit readiness and support for client audits and inspections
Benefit:
You stay inspection-ready and fully supported — with a quality team that works as an extension of yours.
Qualified Person Specialized Expertise
ATMP-experienced Qualified Persons (QPs) and auditors
Design, implementation, and monitoring of Quality Management Systems
Support for technology transfers, supplier/material evaluations, and region-specific compliance
Support for technology transfers, supplier/material evaluations, and region-specific compliance
Benefit:
You benefit from deep regulatory and technical expertise tailored to advanced therapies.
Regulatory Affairs Support
Regulatory interactions with EMA, FDA, and national authorities (e.g., VHP, scientific advice, orphan drug designation)
CMC (IMPD/IND Module 3) preparation and review
Design of stability studies and support for EU GMO approvals
Guidance on national cell and tissue legislation
Validation of laboratory computer systems
Benefit:
You accelerate your regulatory pathway with expert guidance and hands-on support at every step.
More Ways We Help
cGMP Manufacturing and Quality Control
Cell therapy and viral vector
expertise with robust in-house QC capabilities
Lentiviral & Gammaretroviral Vector Production & Testing
Viral vectors development and manufacturing - scalable RUO & GMP grades
Analytical
Development
Analytical development include
method development,
optimization, and validation
Process Development & Tech Transfer
Scalable, optimized processes
with successful transfer from lab to GMP
Apheresis Collection
& Logistics
Seamless needle‑to‑needle coordination across 150+ EU/US legacy apheresis sites — from apheresis to patient delivery
Storage
& Distribution
Proprietary global GxP logistics, controlled storage, and cold chain management
Quality & Regulatory Support & Qualified Person Services
QP batch release under EU GMP and global compliance support
Extensive Global Heritage in Apheresis Management
SCTbio draws on a long-standing legacy of working with more than 150 qualified and trained cell-collection sites across Europe and the USA. We provide dedicated apheresis support, with rapid reactivation and site‑specific procedure alignment to secure high‑quality clinical starting material.
