Key2Compliance has extensive experience in helping companies of all sizes in the medical device industry and Pharma Industry with GxP Services. ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities.GxP covers GCP, GVP, GMP, GLP and GDP primarily and we can support you in all these areas.
Smaller Companies often needs a QA Manager on one or two days a week, we can support you with this as well.
-Audits and Inspection readyness support,
-Vendor , CRO and supplior Audits
-Support with GMP certification for Pharma Production
-GCP, GVP, GMP, GDP and GLP services
-Trainings, Coaching and Support,
-Design of and implementation of an eQMS
-Development of quality related SOPs,
-GMP support for production of drugs to be used in early clinical trials
-System Audits and validations
-Study, Investigator site, TMF and Document audits
-Writing, reviewing and updating SOPs
-Site audits in clinical trials
Just contact Jan Hellqvist for a discussion! firstname.lastname@example.org or +46705612519