Expertise.
Regulatory Affairs.
Efficient?
Secure?
Flexible?
Your path to successful market approval.
Our services include:
- Regulatory strategy: Development of a clear strategy to fulfill all regulatory requirements.
- Submission and communication: Preparation and submission of relevant documents and direct communication with authorities such as the FDA and EMA.
- Compliance management: Implementation of a robust system to ensure compliance.
Ensure smooth market approval.
Our comprehensive services in the area of regulatory affairs.
Regulatory strategy.
- Analysis of specific requirements for national and international markets.
- Development of individual strategies for process optimization.
- Adaptation to new regulatory requirements.
Submission & Communication.
- Efficient creation and submission of relevant documents.
- Direct communication with authorities such as the FDA and EMA.
- Preparation and monitoring of audits.
Compliance management.
- Establishment of a compliance management system.
- Monitoring and adapting to regulatory changes, including EU MDR requirements.
- Training and education to ensure compliance
Successful projects in the field of regulatory affairs consulting.
The challenge
A medical technology company was faced with the task of obtaining approval for a new medical device in several international markets at the same time. The complex regulatory requirements in various countries posed a particular challenge.
Measures
- Development of an international regulatory strategy to harmonize approval processes.
- Preparation and submission of all necessary documents to the relevant authorities.
- Direct communication with health authorities to speed up the approval process.
Results
- Successful market approval in all target markets.
- Shortening the approval process by 30 %.
- Long-term assurance of compliance through implemented processes.
Success
The company successfully launched its product globally and significantly increased its market share.
Take advantage of our expertise for your market access.
Our Regulatory Affairs Consulting Portfolio.
Our experts analyze the regulatory requirements of your target markets, develop individual strategies and adapt your processes to current and future regulations. In doing so, we help you to identify regulatory risks at an early stage and minimize them in a targeted manner. Use our guide to FDA approval or our approach to ISO conformity.
We support you in the preparation, review and submission of all necessary documents. Thanks to our close cooperation with authorities such as the EMA and national regulatory authorities, we can speed up approval processes and make communication efficient. We can also help you prepare for regulatory audits and inspections.
To ensure your long-term compliance, we implement robust management systems and offer customized training for your team. Our continuous monitoring and adaptation of your systems ensures compliance with all regulatory requirements - even with complex changes such as the requirements of the EU MDR.
We help you to monitor your products even after market approval to ensure regulatory compliance. Our team offers preventive measures to minimize risks and supports you in the analysis of market and safety data.
Further information can be found on our page on post-market surveillance and risk management.
Thanks to our international expertise, we support you in opening up new markets. With comprehensive support in the area of Global Market Access, we ensure that your products meet regulatory requirements worldwide.
