PharmaRelations leading Audit Expert
PharmaRelations is market leader in the Nordics performing many types of audits in the field of Good Practices (GxP) and ISO compliance audits
- Good Pharmacovigilance Practices (GVP)
- Good Clinical Practices (GCP)
- Good Manufacturing Practices (GMP)
- Good Distribution Practices (GDP)
- Computerized System Validation (CSV
Our expertise covers all areas within Life Science such as pharmaceuticals, medical devices, combination products, cosmetics, food and food supplements. Our team of Senior Audit Experts has performed significant amounts of audits in the industry and five of them have experience as working as Inspectors within GVP, GMP and GDP at Competent Authority as former employees of the Swedish Medical Products Agency (MPA).
We provide Senior Experts within each area that you need and undertake audits globally in all geographies. We support you with internal audits of your systems and external audits of your partners´ and vendors´ systems. We also support you with mock inspections in preparation for Competent Authority and Notified Body Inspections and can also support you before, during and after you are being inspected.
Not the least, we make sure you are inspection ready by supporting you with finding and implementing solutions to the gaps that we find in your processes and systems during gap analysis. We provide customized trainings for audits and inspection to improve your knowledge, preparation and readiness. Why not let a former Competent Authority Inspector guide you to a successful outcome of your next Inspection!
Emma Axelsson recently joined as Head of our Medical Device teamEmma Axelsson has joined PharmaRelations from the Swedish Medical Products Agency where she worked as a Medical Device Assessor and Inspector, with a prior long career as Chief Executive Officer (CEO), Chief Operating Officer (COO) and Senior Quality Consultant within medical device consulting services, as well as QA/RA Manager at two different medical device start-ups. We look forward to support and advise our clients within Medical Device with audits, technical documentation, quality management, CE-marking, the role of Person Responsible for Regulatory Compliance (PRRC) and much more.
Emma Axelsson emma.axelsson@pharmarelations.com |
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Digital competence build-up both for advisor services and interim services
PharmaRelations is providing an increasing pool of digital competences within our businesses, with focus on selection and implementation of software as well as gap analyses and data migration.
Helena Björkman
helena.bjorkman@pharmarelations.com
90 specialists within Compliance services, consulting, outsourcing and interim in the Nordics
Helena Björkman is leading a large team of experts across the Nordics within Pharmacovigilance, Quality Assurance, Regulatory Affairs, both within Pharmaceuticals and Medical Device. We have large team of specialists in place in various areas and at various seniority.
Contact Helena Björkman for pan-Nordic services within the Compliance spectrum.
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Kristina Edholm
Helena Marteus
