Services & Expertise

Qualified Person Services

• QP services for investigational medicinal products (IMPs)

• QP services for authorised medicinal products

• QP services for APIs requiring manufacturing authorisation pursuant to Section 13 AMG

• GMP compliance, batch certification and release support

• Inspection preparation and authority interactions

Development & Manufacturing

• Pharmaceutical and CMC development strategies

• Manufacturing process development, optimisation and troubleshooting

• Technology, process and analytical transfers

• Support from early development through commercial supply

Quality Management & Quality Control

• Pharmaceutical quality systems, quality assurance and quality control

• GMP compliance, gap assessments, inspection readiness and remediation

• Compilation and negotiation of Quality Agreements

• Supplier qualification, deviation, CAPA and change control support

Regulatory Affairs

• CMC strategy, dossier preparation and lifecycle management

• Regulatory assessment of development, manufacturing and transfer activities

• Authority interactions and responses to questions

• Regulatory support for IMPs and authorised medicinal products

Business Development & Contracting

• Business development and strategic partnering

• Contracting, sourcing and supplier selection

• In- and out-licensing

• Due diligence and product portfolio evaluation

Project Leadership & Interim Management

• Cross-functional project leadership

• Interim management across development, quality, manufacturing and regulatory affairs

• Product launches, portfolio transfers and supply-chain projects

• International stakeholder and external partner coordination

Selected Projects

Selected project experience and references are available upon request, subject to confidentiality obligations.