QP Services
Ensuring Regulatory Compliance and Product Quality
Are you seeking expert QP service to ensure the highest standards of quality, safety and regulatory compliance for your pharmaceutical products?
With a deep understanding of EU Good Manufacturing Practice (GMP) requirements – particularly Annex 16 – and a strong track record in global regulatory frameworks, I provide end-to-end QP services that are fully aligned with current legislative expectations.
- GMP certified / EU QP registered
- Registered as QP in Germany: Expertise in accordance with §15 (1), (3) (3a) AMG and recognition as a Qualified Person (QP) by the Tübingen Regional Council in accordance with § 14, § 15 and § 19 AMG
- Registered as QP in Austria according to §7AMBO
Comprehensive QP Services for Pharmaceutical Manufacturers
From batch certification and release to oversight of manufacturing and supply chain activities, I offer a comprehensive and adaptable service portfolio. Whether you’re a contract manufacturer, importer or a marketing authorization holder, my QP services are tailored to meet your specific needs, ensuring product integrity, risk mitigation and seamless regulatory interactions.
01
Batch Certification
& Release
02
Clinical Trial & IMP Service
Investigational Medicinal Products (IMP):
QP certification and release of IMPs per Annex 16 under consideration of Annex 13. Ensuring investigational medicinal products (IMPs) are manufactured, tested and handled in compliance with EU GMP and Clinical Trial Regulations (EU CTR 536/2014) or Directive 2001/20/EC (for older trials).
03
Regulatory Support & GAP Analysis
Provide interpretation and application of EU GMP (EudraLex Vol 4) and relevant ICH guidelines. Support in regulatory submissions and responses (e.g., MA variations, inspection follow-ups). Oversight of outsourced GMP activities and third-party manufacturing compliance and importation support and compliance in line with CTR 536/2014 article 61.
GAP Analysis & Product Quality Review (PQR):
Systematically assess existing quality systems, documentation and operational practices against the applicable regulatory standards, identifying discrepancies that could pose risks to product quality or batch certification. Evaluate for trend identification, process consistency and continuous improvement. Detailed review of PQRs and technical documentation to ensure data integrity and regulatory compliance.
04
Training & Consultancy
Custom-designed training sessions for professionals and aspiring QPs and QA staff, covering the latest regulatory updates and industry best practices.
Risk Management & CAPA Advisory:
Expert guidance on risk management, deviation investigations and Corrective and Preventive Actions (CAPA).
Why Partner with an
Experienced QP
Industry Expertise: Years of hands-on experience in pharmaceutical quality assurance and regulatory compliance.
Flexible QP Solutions: Whether you need a long-term contract QP or short-term project support, I provide tailored solutions to suit your business needs.
Commitment to Quality: Dedicated to safeguarding your pharmaceutical supply chain and ensuring regulatory compliance in every batch release.
The Importance of QP Services in Pharmaceutical Manufacturing
In the highly regulated pharmaceutical industry, the role of a Qualified Person (QP) is critical to ensure that medicinal products meet the required quality, safety and regulatory standards. EU regulations mandate that a QP certifies each batch before it can be released to market. Without proper QP oversight, companies risk product recall, regulatory penalties and damage to their reputation.
How My QP Services Can Support Your Business
Accelerate Product Release: Reduce delays and bring your products to market faster with swift batch certification.
Strengthen Regulatory Compliance: Stay audit-ready and avoid regulatory sanctions with ongoing GMP audits and inspections support.
Enhance Product Quality: Benefit from rigorous quality reviews and comprehensive product documentation evaluations.