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Quality Assurance

Quality Assurance

Danish and Norwegian PharmaRelations Country managers 2

Expert QA support to ensure compliance

At PharmaRelations, we specialize in providing high-quality Quality Assurance (QA) consulting services tailored to the unique needs of the pharmaceutical industry. Whether you're preparing for a regulatory inspection, implementing a GMP-compliant quality management system, or managing deviations and CAPAs, our experienced QA consultants are here to support your team every step of the way.

Our consultants bring deep expertise from several roles in the pharmaceutical sector and regulatory authorities. This means we offer not just theoretical knowledge, but practical, inspection-ready solutions that ensure compliance with GMP, GDP, GLP, and GCP requirements.

We deliver flexible QA solutions — from Qualified Persons (QPs) working full-time on-site to part-time remote support from our in-house consultants. We help you build, strengthen, and maintain robust quality systems that meet regulatory expectations and support business growth. 

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Our Core QA Services for Pharma

  • QP/RP Services – Full-time or part-time batch release and regulatory support 
  • Quality Management Systems (QMS) – Implementation and improvement based on EU GMP and ICH standards
  • Audits – Internal audits, supplier audits, mock audits, and regulatory inspection prep
  • Inspections – Preparation, on-site support, and post-inspection follow-up
  • Risk Assessments – Identify, assess, and mitigate quality and compliance risks
  • Qualification and Validation – Including equipment, systems, and cleaning validation
  • Deviation & CAPA Management – Root cause analysis and effective corrective actions
  • Change Control and Life Cycle Management – Ensure control over critical quality processes
  • Due Diligence – QA expertise for mergers, acquisitions, and partner qualifications
  • Quality Agreements – Development and review of compliant third-party agreements
  • GMP/GDP/GCP/GLP Training – Tailored training programs for staff and QA teams 

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Our Expertise

Regulatory affairs Marketing Authorization Marketing Compliance Supplements & Food Cosmetics Nordic Regulatory Affairs Pre-Approval Regulatory Affairs
Medical Writing Medical Affairs
Data Management Sales & Commercialization Digital Marketing
Clinical development Pre-clinical services
Medical Engineering
Market Access
Medical Device and IVD ISO 13485 MDR IVDR MD SW
Global Pharmacovigilance and Drug Safety Pharmacovigilance & Safety Local Pharmacovigilance Pharmacovigilance Audits and Inspections
Quality Assurance
Nordic market entry

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