Regulatory Affairs and Consulting
“Follow the standards, master the quality.”
Navigating the regulatory landscape of clinical trials and medical devices
We’re here to help you navigate the complex regulatory environment of clinical trials and medical devices, and to achieve your goals in full compliance with applicable regulations.
What we do
In the field of clinical trials and medical devices, we provide comprehensive regulatory consulting services. This includes preparing and submitting applications to regulatory authorities, obtaining the necessary approvals, and ensuring full compliance with current regulations and standards.
We design approval strategies for clinical studies, ensure that all phases of development — from conception to market presence — meet regulatory requirements, and coordinate communication with ethics committees and regulatory bodies such as SÚKL or EMA. We make sure that all documents and procedures comply with both national and international norms.
We work closely with regulatory experts, legal advisors, and other specialists to minimize the risk of inconsistencies and to ensure a smooth process — whether it’s a clinical study, market entry, post-market surveillance, or another goal. With our experience and up-to-date knowledge of regulatory changes, we’re ready to help your project move forward without unnecessary obstacles.
Regulatory affairs and consulting
Pharmaceuticals
- Preparation and submission of applications for study/registry approval
- Preparation of documentation for study/registry registration
- Coordination of communication with ethics committees and regulatory authorities, including reporting and notifications
- Ensuring compliance with GxP (Good Clinical Practice) and ICH (International Council for Harmonisation) requirements
- Support with informed consent procedures, study/registry progress monitoring, and regulatory compliance throughout the project lifecycle
- Assistance during audits
Medical devices
- Consulting for medical device market entry, including preparation and submission of certification applications
- Ensuring compliance with EU regulations MDR 2017/745 and IVDR 2017/746
- Support in preparing technical documentation and clinical evaluations
- Communication with notified bodies
- Ensuring correct labeling and documentation in line with applicable legal requirements
Our services include
Quality assurance and management
If you’re unsure how to properly navigate clinical studies or research processes, we’re here to guide you every step of the way. We’ll provide clear instructions on what to do, when, and how — and support you through each phase of your project. Our priority is to ensure high quality, effective project management, and optimal outcomes. We help you reach your goals in compliance with current regulations and best practices.
Consulting
We’re happy to assist with anything within our areas of expertise. Whether you need support in clinical research, data analysis, medical devices, or any other specialized topic, we’re here to help. Let us support you in achieving your objectives.