"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Consulting

Make use of our knowledge in GMP, GDP, Medical Device regulations and Quality Systems requirements.

Our network of compliance experts can help you with assignments in connection with a training activity or as a separate project.

We like assignments where we can either act as a "sounding board" or as part of your team, for example at resource shortages and at workload peaks, and can work both remotely and in meetings on-site.

Examples of assignments where we have assisted our customers :

  • GMP Compliance Auditing of eg. laboratory.
  • CE marking and product registration.
  • Reconciliation of routines / instructions against requirements in GMP, QSR, MDR and ISO 13485.
  • Internal audits and supplier audits.
  • Help upgrading quality system routines and instructions from being based on ISO 13485 to meet FDA requirements (QSReg, 21 CFR 820).
  • Specific advice on relevant QMS and GMP requirements and interpretations, such as validation requirements, risk management, electronic document management, supplier evaluations and laboratory work.
  • Preparations for inspections by authorities.

For the pharmaceutical industry, please send us an email (info@key2compliance.com) or call us (+46 8 544 811 60)

For the Medical Device industry our consultancy activities are handled by our partner Symbioteq Kvalitet AB. With their team of consultants and network of specialists, Symbioteq offers support for quality assurance, risk management, product registration and CE labeling for the Medical Device industry.
For more information and contact, see www.symbioteq.se