PharmaRelations leading Audit Expert

06 November 2024
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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 team

Emma 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




Ulrika Lundahl

ulrika.lundahl@pharmarelations.com

Leading Nordic PV team with 50 associates

PharmaRelations is a pan-Nordic consulting company that working together across the geographic borders. Our strong Nordic PV team counts some 50 people, with local employees in each Nordic country.

We can support you with all types of services within all areas of PV such as Qualified Person responsible for PV (QPPV), Responsible Person (RP), Safety Physician, Veterinarian, Local Responsible PV person (LRPV), global and local literature search, case handling, signal management, risk management, aggregate reports, PV System Master File (PSMF), contracts and agreements, vendor management and deviation and CAPA. We have helped numerous of clients to build their entire PV system and (Quality Management System) QMS from the ground up and other Clients to redesign their PV system to improve and facilitate their processes and systems. We are committed to the compliance of our Clinets.

We also support you within Computerized System Validation (CSV) with advice, selection of digital solutions and validation, implementation, gap analysis and audit of software.



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. 

Specialist recruitment focused on the compliance areas

We have a large recruitment team in total within PharmaRelations, with specialists in all countries.

Kristina Edholm is our Senior Recruitment Manager in Sweden for the spectrum of compliance positions, with Helena Marteus as coordinator for Nordic recruitment assignments.

Contact Kristina Edholm or Helena Marteus for Nordic positions. 






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