Business Solution


KLIFO Quality Assurance Solutions helps manage and ensure the correct level of quality and integrity across every stage of your drug development project. Our quality and compliance solutions are delivered by highly knowledgeable experts with many years of industry experience. We provide practical consulting and operational services related to GCP, GDP, GMP and GVP to ensure that you can fulfil the complex regulatory requirements.

Anne Ploug Jørgensen

Director, QA & QP Delegate

Anne has more than 30 years’ experience in pharmaceutical product development and Quality Assurance. For the past more than 20 years she has worked as a QP delegate. She is an expert in packaging and labelling for clinical trials and has vast experience with design and maintenance of Quality Management Systems. Anne joined KLIFO in 2017.

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.

Our expert staff