Our audit services are built on a foundation of extensive global experience with industry experts ranging from Drug Substance, DrugProduct, and Medical Devices.
We specialize in GMP, GDP, ISO 13485/MDSAP as well as ISO 27001 audits, offering unparalleled insights and compliance solutions.
We invite you to take a look at our experienced auditors below - Please note in the form if you have a preferred auditor in mind.
Please fill out the form and our expert team will contact you within 24 hours.
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Area of expertise: GMP (Drug Substance/Drug Product) incl. Aseptic manufacturing
Per has performed +100 audits spending +10.000 hours on site at drug manufactures on six continents of the world.
He is a trained microbiologist and has performed GMP training since 2010 for companies around the world.
He has hosted GMP authority inspections from e.g. Denmark, Korea, Japan, Russia, China, Brazil as well as prepared and hosted US FDA inspections for NDA and BLA products, and written both 483 and WL responses.
Area of expertise: Certified ISO9001 Lead Auditor
Hanne has performed +50 IT Supplier audits with focus on Quality systems, Software Lifecycle, Cloud (SaaS) solutions and IT security (ISO27001).
She has participated in several FDA audits within Pharma (Drug Substance/Drug Product), and hosted US FDA inspections within MedicalDevices/IVDR.
She has frequently supported IT Suppliers/ Pharma/ Medical Device companies preparing for authority inspections (US FDA, Danish Medicines Agency).
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Area of expertise: ISO13485 certified auditor incl. MDSAP
With more than 20 years of quality and compliance experience within the MedTech area Camilla has performed internal audits and local inspections in global associated organisations and affiliates.
She has also hosted and been the auditee in notified body audits and authority inspections. In other words she can support the full process within the organisation both before and after an audit.
Camilla has trained auditees to ensure awareness of the importance of performance and behaviour at audits, in a way that they feel more confident and secure in the audit situation.
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Area of expertise: GMP (Drug Substance/ DrugProduct/ Regulatory starting materials) and GDP (Wholesalers, Warehouses andTransport companies)
Lotta has performed +50 audits in European countries as well as China, Japan and US. She has been Head of QA, QP, RP and QPPV for some Swedish companies.
She has prepared and hosted GMP authority inspections in Sweden, Saudi Arabia and USA FDA, and GDP/GPV authority inspections in Sweden as well as MDSAP, MDD and ISO13485 Notify Body inspections.
Area of expertise: GMP (Drug Substance/Drug Product), ISO 9001.
Magnus has performed supplier audits, CMO-audits and mock-GMP-inspections in the US, Europe and China on and off during the last 20 years.
He holds M.SC in Engineering and has performed GMP Design Reviews, GMP-trainings and GAP-analyses for manufacturers and suppliers around the world.Magnus has also worked 5 years at the European Medicines Agency with GMP inspections and GMP harmonisation.
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Area of expertise: GMP Pharmaceutical (Drug Substance/Drug Product), GMP Medical Device (ISO ISO 9000, ISO 13485, ISO 14791, ISO 27001, MDSAP, EU MDD-MDR), incl. Validation & Qualification, Computer System Validation and Data Integrity. EU GMP (Annex 1, 11, 15), FDA CFR 21 Part 11 / 210 / 211 / 820, and GAMP 5.
Henrik has over +20 years of experience in GMP compliance, validation, and inspection readiness in Pharma and Medical device. He is a certified Lead Auditor and a recognized expert in GMP, and he has led GMP audits in Europe and the US, hosting inspections from the Danish Medicines Agency, the FDA, and multiple Notified Bodies.
Henrik has provided strategic QA support for sterile production, API/DS manufacturing, and regulated IT infrastructure projects. He is renowned for simplifying technical complexities into clear compliance strategies, aiding numerous greenfield and remediation projects.