We help companies ensure compliant batch certification and maintain full GMP oversight.
The QP role is central to ensuring that medicinal products are manufactured, tested and released in accordance with EU GMP and Marketing or Clinical Trial Authorizations. We provide highly experienced QP support that combines regulatory knowledge, quality oversight and pragmatic business understanding.
Whether you need an acting QP, temporary support, or strategic QP advisory, we provide reliable and inspection-ready solutions tailored to your organization.
We help companies protect patients, maintain supply continuity and ensure regulatory confidence through strong QP oversight.
What We Do
QP Batch Certification & Release
- QP batch certification and release of medicinal products
- QP batch certification of investigational medicinal products (IMP)
- Batch record review and oversight
- Deviation and change control assessment prior to certification
- Oversight of testing, manufacturing and supply chain compliance
QP Oversight & GMP Compliance
- GMP oversight as named QP
- Quality system oversight related to batch certification
- Review of Product Quality Reviews (PQR)
- Ongoing verification of GMP compliance status
- Supplier and contract manufacturer oversight
- Support for importation and release activities
- Support for critical deviation assessments
Investigational Medicinal Products (IMP)
- QP certification of IMPs
- Clinical supply chain compliance support
- Regulatory oversight of clinical manufacturing
- QP declarations for clinical trial applications
- Support for ATMP and complex products
Audit & Inspection Support
- QP support during GMP inspections
- Preparation for authority inspections
- QP presence during regulatory inspections
- Response support for inspection observations
- GMP remediation support
QP Advisory & Interim Roles
- Interim QP services
- Virtual QP support for smaller organizations
- QP mentoring and organizational readiness
- Support establishing QP governance models
- Acting QP during transitions or growth phases
How We Work
Our QP services are based on risk management, transparency and strong regulatory judgement. We focus on creating clarity in complex situations and ensuring well-documented, defensible decisions.
We can act as your QP, provide backup QP capacity or support your internal organization with senior advisory expertise. We work as an extension of your team — fast, accountable, and compliance focused. Engagements range from a few hours to long-term embedded partnerships and guidance.
Who We Serve
- Pharmaceutical manufacturers
- Biotechnology companies
- Clinical stage companies
- Companies with EU GMP manufacturing or importation authorization
- Organizations needing QP backup support
- Companies preparing for inspections or product approval
- Organizations with complex supply chains
