Our Expertise

Quality Assurance

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.

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

Nordic Head of Quality Assurance+46 70 165 22 96kent.wiberg@pharmarelations.se

I have worked as employed in both large and small Pharma companies (AstraZeneca, Fresenius-Kabi, Vironova) and also Agencies (Läkemedelsverket, KemikalieInspektionen) for 26 years, where of 20 years in different management positions. My educational background is PhD in Analytical Chemistry, MSc in Chemistry and I have also LeanSigma BlackBelt certification. In 2022 I started my own company and work since then as sub-contractor and interim manager. My first assignment as consultant was in Sobi during 2022-2026 where I worked as Interim Head of Quality and Interim Head of Analytical Science.