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?

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:

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.

Submission & Communication.

Compliance management.

Successful projects in the field of regulatory affairs consulting.

Our expertise has helped clients accelerate their market access and efficiently fulfill regulatory requirements.

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 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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