We make complex things easier

GBA 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

Auditor / Lead Auditor – Pharmaceuticals and Medical Devices

Dec 4
- Dec 6, 2024
Copenhagen, Denmark
Auditing/Inspection

Strategic communication

Dec 4
- Dec 5, 2024
Copenhagen, Denmark
General, Quality management and QA

Introduction to GMP and Quality Systems

Jan 21
Online
General, GMP

Medical Device Supplier Control and Outsourcing

Jan 28
- Jan 29, 2025
Copenhagen, Denmark
Quality management and QA

Validation and qualification

Mar 5
- Mar 6, 2025
Copenhagen, Denmark
Validation and Qualification

Introduction to Risk-based thinking and Quality Risk Management

Mar 10
- Mar 11, 2025
Copenhagen, Denmark
Risk

Medical Device Quality Management Systems (QMS)

Mar 11
- Mar 13, 2025
Copenhagen, Denmark
Quality management and QA

Effective root cause investigation for the Life Sciences

Mar 13
- Mar 14, 2025
Copenhagen, Denmark
CAPA, Quality management and QA

Auditor/Lead Auditor – Läkemedel och medicinteknik

Mar 18
- Mar 20, 2025
Stockholm, Sweden
Auditing/Inspection, Validation and Qualification

Grundlæggende om GMP

Mar 27
Copenhagen, Denmark
General, GMP

Advanced Training in Biological Evaluation of Medical Devices

May 14
Mölndal-Gothenburg, Sweden
Biocompatibility

Validering och kvalificering

Jun 3
- Jun 4, 2025
Stockholm, Sweden
Validation and Qualification

Requirements to place Medical Device Software and Health Software on the market

Jun 11
- Jun 12, 2025
Copenhagen, Denmark
Computers/Software

GMP Intermediate course

Jun 17
- Jun 18, 2025
Copenhagen, Denmark
QC-lab, Quality management and QA

MDSAP – a global approach

Sep 24
- Sep 25, 2025
Copenhagen, Denmark
Auditing/Inspection, Quality management and QA

Our Customers

Stories about how we support
our customers

Latest Webinars

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

Presented by: Åsa Möllby, GBA Key2Compliance and Ella Wilhemsson, Medos
Tags: Medical Device QA

Presented by: Winta Woldai, GBA Key2Compliance

Tags:
Biological Safety

Presented by: Maria Lindgren, GBA Key2Compliance
Tags: Clinical evaluation

Want to work at GBA 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.

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