Expertise.
Regulatory Affairs.
Optimize your market approval and ensure the compliance of your products with our comprehensive range of services.
Efficient?
Would you like to accelerate your market approval?
Secure?
Do you need reliable strategies to comply with regulatory requirements?
Flexible?
Are you looking for customized solutions that adapt to your requirements?
Ensure smooth market approval.
Your path to successful market approval.
Regulatory affairs is the key to successful market access and long-term compliance.
Our experienced experts support you in mastering complex regulatory requirements. We develop individual strategies, optimize your processes and ensure that your products meet the regulatory requirements of national and international markets.
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.
Our portfolio covers the entire range of regulatory requirements - from strategic planning to operational implementation.
Regulatory strategy.
- Analysis of specific requirements for national and international markets.
- Development of individual strategies for process optimization.
- Adaptation to new regulatory requirements.
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.
Our expertise has helped clients accelerate their market access and efficiently fulfill regulatory requirements.
Successful market approval of a medical device
Approval of a biotechnology product in several markets
Optimization of compliance management for a pharmaceutical company
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 Regulatory Affairs Consulting offers you comprehensive support to bring your products to market successfully and sustainably. From strategic planning to continuous monitoring, we develop customized solutions that meet your regulatory requirements.
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.
Master your regulatory challenges efficiently and sustainably.
Regulatory Affairs - your partner for successful approvals.
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