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Compliance & QP.

Working with our Life Sciences clients to ensure absolute pharmaceutical quality. Batches of medicines or drug products need to be safe, consistent and effective and their production involves much more than pure materials processing.

Glass bottle filled with yellow capsules on an automated pharmaceutical production line with precision machinery.

At a glance

Bringing innovative and safe medicinal products to patients across the globe.

From ensuring that quality is built into the facility design, to the specification and monitoring of equipment and the training of client teams, our compliance experts have a detailed knowledge of good manufacturing practice guidelines and the latest in industry regulation.

This end-to-end experience ensures that strong quality management systems and operating procedures are in place, continually assuring the design, monitoring and control of a client’s manufacturing processes and facilities.

Responsible Persons

Our Responsible Persons (RP) adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines for the pharmaceutical manufacturing and distribution of medicinal products – guaranteeing compliance with quality standards.

Our RPs are a vital link between our clients and the authorities. Clients can focus on their main business activities while we ensure compliance with all regulatory requirements. Our services are flexible and can be tailored to meet specific needs, whether on an interim or mandate basis.

RP services

Services

  • Good Clinical Practice (GCP)

  • Good Distribution Practice (GDP)

  • Good Laboratory Practice (GLP)

  • Good Manufacturing Practice (GMP)

  • Audits & Inspections

  • EU GMP Annex 1 Consulting

  • Authority liaison & inspections

  • Batch releases

  • Complaints, quality defects and CAPA management

  • Controlled substances

  • Product quality reviews (PQRs)

  • Returns and batch recalls

  • Risk management

  • Supplier / customer qualification

  • Quality Agreements

  • Quality Manuals

  • QMS documents

  • QC strategies

  • Method development, optimisation & validation

  • Method transfer

  • Certificates of analysis

  • Devices QC

  • Onsite QC support

  • Stability studies

  • GMP-Konformität & Beschwerden

  • Standardarbeitsanweisungen (SOPs)

  • GMP conformity & complaints

  • Standard Operating Procedures (SOPs)

Team

Kilian Weber

Kilian Weber

Associate Engineer - Process

Lisa Craig

Lisa Craig

Director, Process

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