Quality Assurance Services
At Interdos, we provide practical QA support tailored to the needs of pharmaceutical and healthcare companies. Our experienced team helps clients build, maintain and improve compliant quality systems, with a strong focus on solutions that work in day-to-day operations.
Our services cover Quality Management System (QMS) maintenance, SOP development, GMP/GDP audits, training and compliance support, RP and QP services, supplier quality management, and applications for Manufacturing and Wholesale Distribution Authorisations.
Whether you need ongoing QA support, additional expertise for a specific project, or guidance through a regulatory challenge, our team works alongside you to keep your quality system compliant, effective and ready for inspection.
-
-
Quality Assurance throughout the product lifecycle
Maintaining pharmaceutical quality and regulatory compliance requires the right expertise, systems and oversight.
Interdos provides practical GMP and GDP Quality Assurance support tailored to your organisation. From maintaining your Quality Management System and performing audits to providing QP/RP expertise and supporting licence applications, our QA professionals can strengthen your existing team or provide dedicated quality support where needed.
Our QA Services
-
Quality Management System Maintenance
A well-maintained Quality Management System is the foundation of GMP and GDP compliance. We support the implementation, maintenance and continuous improvement of your QMS.
Our support includes:
- QMS implementation and maintenance
- SOP development and review
- Deviations, CAPAs and Change Controls
- Product Quality Reviews (PQR/APQR)
- Supplier qualification and management
- Customer qualification and management
- Quality risk management
- Training and GMP/GDP compliance
- Self-inspections and inspection readiness
- Quality documentation and periodic review
- Validation Plans and Reports
Whether you need targeted QA support or ongoing maintenance of your quality system, our approach is adapted to the size, activities, and needs of your organization.
-
Access experienced pharmaceutical quality professionals when your organization requires Qualified Person or Responsible Person support.
Qualified Person (QP):
- EU batch certification and release
- GMP compliance oversight
- Assessment of manufacturing and testing documentation
- Review of deviations and quality issues impacting release
- Supply-chain and contract-manufacturer oversight
- Support with regulatory inspections
- QP declarations and GMP-related assessments
Responsible Person (RP):
- GDP Quality Management System oversight
- Wholesale distribution compliance
- Supplier and customer qualification
- Deviation, CAPA and change oversight
- Management of returned, rejected or recalled products
- Self-inspections
- GDP training
- Regulatory inspection preparation and support
Interdos can provide ongoing QP/RP support or additional capacity when temporary or specialist expertise is required.
-
Setting up or expanding pharmaceutical operations often requires interaction with national competent authorities and a clear demonstration that the organization is ready to operate compliantly.
Interdos supports applications and changes relating to Manufacturing and Importation Authorizations (MIA) and Wholesale Distribution Authorizations (WDA).
We can support you with:
- Preparation of new license applications
- Changes or extensions to existing licenses
- Assessment of regulatory requirements
- Preparation and review of required documentation
- Site Master File and supporting quality documentation
- QMS readiness and gap assessments
- Preparation for authority inspections
- Follow-up of inspection findings and CAPAs
Our aim is to make the application process structured, efficient and inspection-ready.
-
Independent audits provide confidence that your internal operations, suppliers and partners continue to meet the required quality standards.
Interdos performs risk-based GMP and GDP audits tailored to the organization, product, and activities being assessed.
Audit services include:
- Supplier and service-provider audits
- Contract manufacturer and laboratory audits
- GMP/GDP compliance audits
- Internal audits and self-inspections
- Audit planning and agenda preparation
- Audit execution by experienced QA professionals
- Clear and risk-based audit reports
- Classification of observations
- CAPA review and follow-up
- Supplier qualification support
From audit preparation to final reporting and follow-up, we provide an independent assessment focused on both compliance and practical improvement.
-
-
-
-
Flexible QA Expertise
Meet our QA Team
Support where you need it
Quality Assurance needs are not always permanent or predictable.
Interdos can support your organisation for a specific project, temporary assignment or long-term partnership. Our QA professionals work alongside your organisation to provide practical solutions while keeping regulatory compliance and product quality at the centre.
Need additional QA expertise?
Talk to our Quality Assurance team about your organisation, project or compliance challenge.