Quality Management in Pharma – Compliance, Safety & Excellence
Quality is no coincidence – it is the result of welldesigned processes, lived responsibility, and continuous improvement.
At MSK, we see ourselves as practical partners who translate theoretical expertise into concrete, companyspecific operational solutions. Our focus is on the development, adaptation, and active support of tailored Quality Management Systems (QMS) precisely aligned with the requirements of the pharmaceutical & healthcare, and medical technology industries.
Whether regulatory compliance, operational efficiency, audit preparation, or strategic development – we support you with a comprehensive portfolio of services in quality management, quality assurance, and compliance.
Quality with Integrity
Quality does not happen by chance – it is the result of attention, teamwork, and a shared commitment to delivering the very best. For us, QA is not about finding mistakes, but about building trust: in our processes, our products, and above all, in one another. True quality emerges where people work together with care and responsibility.
Saskia Maurer – Quality Assurance Manager
QMS Pharma – Tailored, Compliant, Audit-Ready
As a full-service partner for pharmaceutical quality management, we support you from consulting and documentation to the implementation and maintenance of your QMS. We design systems compliant with ISO 9001, ISO 13485, GMP, and GDP – tailored to your regulatory needs.
Upon request, we can also take on legal roles such as Head of Quality Management (QMB), Responsible Person for Wholesale Distribution, or Qualified Person, ensuring your QMS is effectively embedded in daily operations.
Our QMS services include:
- Quality management consulting: Specialized advisory for pharma and medical technology in accordance with GDP, GMP, and ISO 13485
- QM / SOP development: Creation of Standard Operating Procedures (SOPs), QM manuals, Site Master Files, records, and forms
- Auditing (GMP/GDP): Support during regulatory inspections, auditing and modernization of QMS, and execution of self-inspections
- Market release in accordance with Annex 16
Driving Excellence with MSK: Process-Optimized Quality Assurance for Pharma & Healthcare
Our experienced consultants address your specific requirements, clarify needs, and take on We take on the comprehensive planning and design of your QM processes and, with expertise and commitment, deliver scalable solutions to secure the quality of your supply chain.
Our services go beyond consulting, planning, and building your QMS: we provide continuous support, organize the monitoring of your processes and QMS, and stand by your side whenever questions arise.
At MSK, quality is not just a task – it is a shared journey. Let’s plan and implement your individual quality strategy together.
Our focus areas:
- Quality management consulting for pharma start-ups
- Holistic pharmaceutical quality assurance across the entire value chain
- Supplier qualification for pharma in Germany & the EU
- Support for internal and external GMP audits
- Compliance checks & regulatory consulting for EU approvals
Looking for quality management support? You’re in the right hands.
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