We make complex things easier

Key2Compliance® offers complete and optimised solutions within Regulatory compliance.

We can create processes and quality management systems that ensures the quality of your business and fully adapted to your organization. No more worries when the next audit appears.
We help you plan, perform, and document the biological evaluation as well as other preclinical studies or the analytical performance evaluation, with the safety of patients in mind. We also perform toxicological risk assessments.
Our team of regulatory specialists can support and guide you through the entire regulatory process for your product, from idea to market, in exactly the way you need it and in the specific market where you want it to be.
We provide quality assurance services related to GCP, GVP, GMP, GDP and GLP to help you fulfill all complex regulatory requirements and ensure the quality of your product
We are experts on clinical evaluations and investigations and will tailor the solution for the client’s product based on competence and experience, working as part of the client’s team.
We offer world-class training for Pharmaceutical and Medical Device companies. View our tailored program with in-house, on-demand and public courses.

Upcoming Courses

Fördjupningskurs i CGMP för läkemedelstillverkning

Nov 15
- Nov 16, 2023
Stockholm, Sweden
Quality management and QA

Grundlæggende om GMP

Nov 20
Copenhagen, Denmark

Sterilization of Medical Devices

Nov 20
- Nov 24, 2023
Copenhagen, Denmark
Auditing/Inspection, Bioburden, ISO 11737, Sterilization, Validation

Auditor / Lead Auditor – Pharmaceuticals and Medical Devices

Nov 28
- Nov 30, 2023
Copenhagen, Denmark

EU Annex 1 – Manufacture of Sterile Medicinal Products

Nov 28
- Nov 29, 2023
Copenhagen, Denmark
Cleanrooms and cleaning, Sterile products

Strategic communication

Dec 6
- Dec 7, 2023
Amsterdam, Netherlands
General, Quality management and QA

Medical Device Quality Management Systems (QMS)

Dec 6
- Dec 8, 2023
Copenhagen, Denmark
Quality management and QA

Validering och kvalificering

Dec 7
- Dec 8, 2023
Stockholm, Sweden
Validation and Qualification

Cleaning validation of pharmaceutical process equipment

Dec 12
- Dec 13, 2023
Copenhagen, Denmark
Cleanrooms and cleaning, Sterile products, Validation and Qualification

QA/RA Leader Medical Devices

Dec 13
- Dec 15, 2023
Copenhagen, Denmark
Quality management and QA, Regulatory Affairs

Auditor/Lead Auditor – Läkemedel och medicinteknik

Mar 13
- Mar 15, 2024
Stockholm, Sweden
Auditing/Inspection, Validation and Qualification

GMP-krav på datoriserade system

Mar 21
- Mar 22, 2024
Stockholm, Sweden
Jan Hellqvist, CEO

“Our most important asset is our dedicated staff. Our team consists of specialists from all over the world, with long and broad expertise in all aspects of the development of medical devices and in vitro diagnostics. It is the team that makes the difference!”

Jan Hellqvist – CEO

Latest Webinars

We love to share our knowledge. Enjoy our webinar library to get the latest insights and expert knowledge.

Want to work at Key2Compliance®​

Picture yourself at one of the best places to work, surrounded by teams and people who challenge you, support you, and inspire you to be extraordinary. Key2Compliance offers more than a job. We offer limitless opportunities to make a difference for our customers and improve patient safety. Join us today.



For your best experience are we using cookies on this website.