QUALITY ASSURANCE SOLUTIONS

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Business solution

KLIFO Quality Assurance Solutions helps manage and ensure the correct level of quality and integrity at every stage of your drug development project.

Our quality and compliance solutions are delivered by our highly knowledgeable and experienced industry experts.

We provide practical consulting and operational services related to GCP, GDP, GMP and GVP, to ensure that you can meet the complex regulatory requirements.

Erik Zobel
Senior Director, QP & RP
Erik has 20+ years of solid experience with all quality aspects of the pharmaceutical industry, including experience as Qualified Person and lead auditor. He joined KLIFO in April 2022 and prior to this, he was head of QA for a Danish pharmaceutical company. Erik has worked in various leadership positions in a number of biotech and pharmaceutical companies. He holds a Master in Pharmacy from University of Copenhagen and a Graduate Diploma in Business Administration from Copenhagen Business School.
Phone: +45 44 778 759

Expertise &
therapy areas

Expertise:

KLIFO Quality Assurance Solutions has a wide and in-depth experience in quality issues for IT and all GxP areas such as GCP, GDP, GLP, GMP and GVP:

  • GCP audits of GCP systems, Investigator sites and CROs
  • GVP audits of Pharmacovigilance partners, systems and affiliates
  • QP audits of CMO according to EU GMP or 21 CFR
  • Audit of suppliers/vendors
  • QP declarations for import into EU
  • QP certification of IMP for clinical trials
  • Acting as QP for small Danish companies
  • Designing and performing tailor-made training courses after your requirement
  • QA counselling and support within all GxP areas
  • Designing of QMS within all GxP areas, including writing of basic quality related SOPs
  • QA strategy, planning and creating the setup for drug development

KLIFO has a broad range of capabilities when it comes to managing quality assurance related tasks. Our GMP expertise covers biologics, small molecules and the complex challenges of Advanced Therapy Medicinal Products (ATMPs).

Our team of highly qualified and trained experts are accustomed to working across these different specialty areas and to meeting the customer needs of our various clients. This knowledge-base and competency enables us to provide solutions that are best suited to our clients’ specific requirements.