Professional Services
Qualified Person (QP) Services
EU QP release of investigational and commercial products, including ATMPs, biologics, and small molecules. Support with IMPD review, dossier compliance, and post-release obligations.
- Batch certification under EU GMP
- Clinical trial product release (GCP interface)
- Support for disposition process, QP declarations, tech transfer, and site readiness
GMP Audits & Inspection Readiness
Internal audits, mock inspections, and supplier audits to ensure your operations meet global GMP expectations.
- Inspection preparation and remediation (EMA, FDA, IGJ)
- Audit execution (as Lead or SME)
- Third-party audit support (CMOs, CROs, suppliers)
Quality Management Systems (QMS)
Build, assess, or optimize your QMS for phase-appropriate compliance and efficiency.
- QMS design and implementation
- SOP development, deviation/CAPA handling, training systems
- Digitization and QMS tooling, experience with different systems
GMP Training & Team Development
Build a quality-driven culture with practical, personalized training for GMP compliance, QMS operations, and regulatory expectations.
- Onboarding programs for new QA/production staff
- Custom training on deviations, CAPA, audit readiness, and QP release
- GxP refresher sessions tailored to ATMPs, biotech, and IMPs
- Development of site-specific training matrices and documentation
- Internal QP mentoring and coaching for emerging leaders
New Product & Market Launches
Seamless GMP support for the introduction of new therapies, sites, or markets — with QP oversight from clinical through commercial scale.
- Site readiness assessments and pre-approval inspection prep
- QP review of Engineering and PPQ batches
- Support for regulatory filings, QP declarations, and product licensing
- Launch coordination across QA, regulatory, and supply teams
- Oversight of serialization, labeling, and shipping compliance