Expertise.
Regulatory Affairs.
Efficient?
Secure?
Flexible?
Ensure smooth market approval.
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.
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 medium-sized pharmaceutical company was faced with the task of implementing new EU regulations in order to avoid potential sanctions. However, the internal structure was not prepared for the requirements.
Measures
- Carrying out a comprehensive compliance analysis to identify weaknesses.
- Development and implementation of a customized compliance management system.
- Intensive training of employees to understand and implement the new requirements.
Results
- Timely implementation of EU regulations within six months.
- Improvement of internal processes and documentation.
- Minimizing the risk of compliance violations.
Success
The company secured its market position and avoided potential fines.
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.
