Quality Management Systems (QMS)
A solid quality foundation for clinical trials and regulatory requirements.
Herlev Pharma Service helps biotech companies establish and operate robust quality management systems. We also provide quality support to parallel importers – always tailored to the company’s organisation, regulatory responsibilities, and specific needs.
QMS Implementation
An effective quality management system is essential for the efficient management of clinical trials, suppliers, and critical quality processes.
Herlev Pharma Service provides a complete QMS solution developed for biotech companies preparing for Phase I clinical trials. The solution is based on the applicable requirements of ICH GCP E6(R3) and the EU Clinical Trials Regulation and is tailored to your organisation and workflows.
A typical QMS consists of 15–18 SOPs with accompanying templates and training materials.
The solution may include:
- Quality manual and fundamental GxP processes
- Good Documentation Practice
- Training and documentation of competencies
- Risk management
- Supplier selection and qualification
- Audits of GxP suppliers
- Sponsor oversight and management of delegated activities
- Reporting and management of serious GCP breaches
- Conduct of clinical trials
- Safety reporting and medical monitoring
- Clinical supply chain management
A Structured Implementation Process
We manage the project throughout the entire process, ensuring that the quality management system is tailored to your organisation and integrated into your existing workflows.
01
Assessment & Planning
We begin with a workshop to review your organisation, current processes, and operational needs. Based on this assessment, we agree which SOPs should be included and how they can best be adapted to your way of working.
02
Prioritisation & Development
We prepare a prioritised delivery plan based on the complexity and interdependencies of the documents. Work on the most comprehensive SOPs begins early, allowing sufficient time for internal review and implementation.
03
Collaborative Review
The SOP authors work directly with the client’s relevant subject-matter experts. As a general rule, we recommend two rounds of review to ensure that amendments are incorporated correctly and that consistency is maintained throughout the quality management system.
04
Approval & Handover
Following the final review, the documents are approved by the client. We then hand over the complete quality management system, including the agreed templates and training materials.
Regular status meetings ensure progress, prompt clarification of questions, and clear responsibilities throughout the process.
Ongoing Quality Support
We also support companies that already have an established quality management system but require additional resources or specialised QA expertise.
Our specialists can become a flexible extension of your organisation, supporting both day-to-day quality operations and clearly defined projects. This gives you access to experienced professionals without necessarily having to recruit additional employees.
We can assist with:
- Outsourcing of the QA function
- Drafting, reviewing, and maintaining SOPs
- Project management for QMS implementation
- Preparation of quality agreements
- Audits of GMP manufacturers, CROs, and other critical suppliers
- Supplier qualification and supplier quality management
- Quality Management Reviews
- Ongoing assessment and improvement of the quality management system
Our team has experience in areas including quality assurance, QP responsibilities, CMC development, and the implementation of quality management systems.
Ready for an Initial Discussion?
Contact us for a no-obligation discussion about your needs and available options, and we will identify the solution that is right for you.