Expand, embrace, and ensure quality

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!

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Our QMS Packages

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.

Features

QMS Structure Compliant

Document implementation

Technical Documentation*

Mock Audit / Self Inspection

Hours of Initiation Training

Length of Plan

CHF 4’999

(one off)

eQMS System (see here)

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

CHF 4’999

(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

CHF 1’999

(per month)

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

CHF 3’999

(per month)

eQMS System (see below): Optional

Detailed Information

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. 

Additional Support

Documentation to comply with additional standards (ISO and other)

GDPR support (24/7/365 EU presence), DPO services