About Real regulatory ltd
Real Regulatory Ltd: Your Trusted Partner in European Regulatory Affairs
Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, with a focus on development. The company has been providing regulatory support to clients across various industries for over a decade, helping them navigate the complex regulatory landscape of the European Union (EU).
At Real Regulatory Ltd, we understand that navigating the EU regulatory environment can be challenging and time-consuming. That's why we offer our clients comprehensive support throughout the entire product lifecycle - from early development to post-marketing activities.
Our team of experts has extensive experience working with regulatory authorities across Europe, including the European Medicines Agency (EMA), national competent authorities (NCAs), and ethics committees. We have successfully supported numerous clients in obtaining marketing authorisations for their products, as well as managing post-approval activities such as variations and renewals.
We pride ourselves on our ability to provide tailored solutions that meet our clients' specific needs. Whether you are a small start-up or a large multinational corporation, we can help you achieve your regulatory goals efficiently and effectively.
Our services include:
Regulatory Strategy Development
We work closely with our clients to develop robust regulatory strategies that take into account their specific product characteristics and target markets. Our team has extensive knowledge of EU regulations and guidelines, enabling us to provide expert advice on all aspects of product development.
Preclinical & Clinical Development Support
We provide comprehensive support throughout preclinical and clinical development phases, including protocol design, study management, data analysis & interpretation, safety reporting & pharmacovigilance.
Marketing Authorisation Applications
We have extensive experience preparing high-quality marketing authorisation applications for various types of products (e.g., pharmaceuticals, biologics). Our team ensures that all necessary documentation is submitted accurately and on time to maximise chances of success.
Post-Marketing Activities
We assist our clients in managing post-approval activities such as variations, renewals, and line extensions. Our team has a deep understanding of the regulatory requirements for these activities and can help ensure compliance with all relevant regulations.
Regulatory Compliance & Auditing
We provide expert advice on regulatory compliance issues and conduct audits to identify potential areas of non-compliance. Our team can help you develop corrective action plans to address any identified issues.
At Real Regulatory Ltd, we are committed to providing our clients with the highest quality regulatory support services. We pride ourselves on our ability to deliver results efficiently and effectively, while maintaining the highest standards of professionalism and integrity.
If you are looking for a trusted partner in European Regulatory Affairs, look no further than Real Regulatory Ltd. Contact us today to learn more about how we can help you achieve your regulatory goals.