Regulatory Strategy Development: We develop regulatory strategies for MedTech and Biotech companies to navigate complex regulations effectively. This involves determining the most efficient path to get products approved by global regulatory bodies such as the FDA (U.S. Food and Drug Administration), Notified Bodies or the EMA (European Medicines Agency).
Regulatory Submission Preparation: We prepare documentation required for regulatory approvals. This includes drafting and reviewing submissions for premarket approval applications (PMA), 510(k) notifications, and CE marking applications (Clinical and Performance Evaluation Reports). We review the technical file to make sure all red flags are raised and solved before submission to the regulatory authority (e.g., Notified Body).
Regulatory Compliance Assistance: We help ensure that medical and biotechnology devices comply with the necessary regulatory standards for quality, safety, and efficacy. This involves understanding and applying harmonised standards (EN/IEC/ISO), Good Manufacturing Practices (GMP), and other regulatory compliance requirements.
Keeping Updated with Global Regulations: We keep you informed about changes and updates in regulatory laws and guidelines across different regions and countries.
Post-Marketing Clinical Follow-Up (PMCF) gap analysis: Let's find the gaps in clinical evaluation & performance studies
Post-Marketing Surveillance Update Report (PSUR): Get your PSUR peer-reviewed & published in a indexed medical journal
We work with a wide network of PhD scientists in different biomedical fields to personalize each team to the unique needs of a medical product. I, Catarina Carrão, strategise the team according to the needs of the project, budget and timelines.
Previously, I worked in medical academic research for more than 15 years in different international institutions (e.g., Yale University). Throughout the years, I've authored several peer-reviewed medical articles, and was honoured to receive the European Science Slam award - a testimony of my creativity, enthusiasm and ability to communicate science to lay audiences. I'm is able to distill complex scientific ideas in a way that is both informative and entertaining.
In 2006, I was a Marie-Curie Early Stage Researcher (Universitätsmedizin Charité Berlin). In 2011, a Postdoctoral fellow at the Yale Cardiovascular Research Center (YCRC). In 2013, I was honoured Fellow of the American Heart Association (FAHA). In 2012, received the European Science Slammer title. And, in 2021 I was nominated Young Science Journalist of the Year by the Association of British Science Writers (ABSW).
My scientific expertise in neuroscience, cardiovascular, oncology, molecular biology and biostatistics allows me to understand the clinical writing needs of innovative medical devices; and, support manufacturers in navigating the regulatory waters of certification.
I'm an active delegate of the Regulatory Affairs Professional Society (RAPS), the best way to have the latest insights on the global regulatory affairs landscape.
In 2022, my work "Creativity in Regulatory Affairs" was selected for the RAPS annual conference. In 2023, I presented "How to use Total Product Life Cycle and Good Machine Learning Practice as your lighthouse when developing and deploying Artificial Intelligence-enabled Medical Devices" at the RAPS Euroconvergence 2023, in Amsterdam. In Eurconvergence 2024 (Berlin) I will talk about "Randomized Clinical Trials vs. Validation Cohort Studies of Artificial Intelligence/Machine Learning-enabled medical devices" and "Effective strategies for high quality clinical data collection through post-market clinical follow-up surveys and medical device registries".
I'm also an accredited science and medical journalist by the World Federation of Science Journalists WFSJ and the Medical Journalist Association MJUK, with several authored articles in different media platforms.
Regulatory Science and policy are my interests, with a wish to see the field moving forward as a way to assess the safety, efficacy, quality, and performance of all medical-related products.
Send us an email:
or, give us call (also on WhatsApp):
+436601590096
The first 30 min of consultation are FREE and come with a smile!
E-mail: contact@bioscipons.com
By understanding the importance of writing and wording, not only in written form to peers but also to deliver valuable information to the consumer, BioSciPons is favoured by start-ups, small-medium enterprises (SMEs) and also big enterprises in the medical and biotechnology field.
Tel: +436601590096
Gentzgasse 73
Vienna - Wien
1180
Austria