QUALITY is key for product development success and should be at the forefront of what your company stands for. We offer flexible and supportive packages to help you find the optimal solution. GO now, GROW alongside us and manage your QMS like a PRO from today, to ensure great QUALITY tomorrow!
We offer 3 different packages to help you create and implement your own Quality Management System for pharmaceuticals products or medical devices/in vitro diagnostics, compliant with EU, US and CH guidelines and regulations.
GO
QMS Structure Compliant: ✔️
Document implementation: You1
Technical Documentation*: Hourly rate2
Mock Audit / Self Inspection: Optional5
Hours of Initiation Training: 4
Length of Plan: One-off
eQMS System (see below): Optional
GROW
QMS Structure Compliant: ✔️
Document implementation: Collaboration
Technical Documentation*: 150 hours3
Mock Audit / Self Inspection: 1 Mock Audit
Hours of Initiation Training: 8
Length of Plan: 12 months
eQMS System (see below): Optional
PRO
QMS Structure Compliant: ✔️
Document implementation: Collaboration
Technical Documentation*: 700 hours4
Mock audit / Self Inspection: 2 Mock Audits
Hours of Initiation Training: 16
Length of Plan: 24 months
eQMS System (see below): Optional
1 Cross reference matrix provided, we can offer support on an hourly rate basis.
2 Additional cost per hour is CHF 200.
3 Additional cost per hour is CHF 175.
4 Additional cost per hour is CHF 150.
5 A mock audit of 8 hours would cost CHF 1,600.
* We will send you a monthly report of the hours you have used to ensure you make the most of them. Once the contract time period has ended, the unused hours cannot be carried forward.
To upgrade from one package to another, any costs already paid for the previous QMS package will be carried forward to allow you to upgrade to a package which offers you more support.
