BioSciPons is a life sciences communication agency. 
It bridges the gap between science and people, academia and business, regulatory agencies and MDR/IVDR manufacturers.

A bridge between two worlds.

Services

If your medical or in-vitro diagnostic device needs approval to market:
BioSciPons can prepare the documentation and write the literature review.

If you need a regulatory science-based workshop :
BioSciPons can do the talking.

If you need to communicate your R&D findings in a simple language:
BioSciPons can do the writing.

   
BioSciPons:
   Translating complex science into the real world.

           Creative thinking at your service!


BioSciPons works from any starting point for a customised service: 

an idea, a dataset, a book chapter, a scientific report, or the simple need to put a safe device into the market.


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Small BioSciPons delivers customer-specific-made contents, in the format that best suits your company:
  • Clinical Evaluation Reports (CERs) for Medical Devices (MDR) and In-vitro Diagnostic Devices (IVDR): experience with high risk classified devices, SaMD, cosmetics, chemical and combined-drug devices
  • Summary of Safety and Clinical Performance (SSCP), for health-professional/user & patient's sections of the Technical File
  • EU MDR & IVDR State-Of-The-Art (SOTA) and Clinical Literature Reviews (MDR 2017/745 & IVDR 2017/746)
  • FDA 510(K) submissions
  • Secondary literature research: Gap analysis for Post-Marketing Clinical Follow-Up (PMCF)
  • Surveys for Post-marketing Surveillance (PMS)
  • Clinical Study Reports (CSR)
  • eBooks
  • Whitepapers
  • Science manuscripts
  • Science blogs with undercover science marketing concepts
  • Workshops (e.g., EU MDR & IVDR, MIRs...)
  • Infographics
  • Technical reports
  • Educational products (e.g., book chapters, brochures, manuals)
  • Grant proposals: expertise European Innovation Council (EIC), Small Business Innovation Research (SBIR)
  • Systematic Reviews
  • Ethics Commission submissions
  • Press releases, ...


You tell us what you need, we do the thinking!


About:


Catarina Carrão

I’m Biochemist and worked in biomedical research for the past 15 years. 

I work with a wide network of scientists from different fields (neuroscience, oncology, drug discovery, geneticists, dermatologists, etc...) to assure the most accurate writing. My own expertise lies in cardiology, neurology and oncology, all the research fields I worked throughout the years.

I have extensive experience in clinical research, scientific writing and biostatistics. The results of my research work as a Marie-Curie Early Stage Researcher in the Cardiovascular Center of the Charité (Berlin, Germany) led to a clinical trial for the treatment of patients with ischemic heart disease. I was award a Grant from the Boehringer Ingelheim Funds, which allowed me to spend several periods in the USA.

Innovation and creativity help me solve technical problems efficiently. When I was a researcher at the Yale Cardiovascular Research Center, I developed new techniques in order to optimize our group results. I served as a liaison from my laboratory to several collaborating labs in Yale and in other institutions. My most recent publication from this group was just approved for publishing in January 2019. Part of the work that I did in 2010 was still innovative after 9 years to be published in one of the most prominent journals of the field. 

I understand the importance of writing and wording, not only in written form to peers but also to deliver valuable information to the consumer. As an example, I was honored to receive the Vienna and the European Science Slam award, and was nominated Young Science Journalist of the Year (2021) by the Association of British Science Writers (ABSW). My presentation entitled "Creativity in Regulatory Affairs: lessons learned from the COVID-19 pandemic" was accepted to the Regulatory Affairs Professional Society (RAPS) 2022-EuroConvergence meeting.

My way of communicating science to a lay audience, testifies my creativity, enthusiasm and ability to communicate science effectively. I am able to distill complex scientific ideas for a broad audience in a way that is both informative and entertaining.

Clinical Evaluation Reports, Medical Systematic Literature Reviews, FDA and EU MDR & IVDR are a staple at my desk. There is nothing clearer than reading medical regulation!

I enjoy working with start-ups or accomplished businesses; and, help them clarify their regulatory path to market or re-certification, particularly under the new MDR (EU) 2017/745 and IVDR 2017/746.

Ana Catarina Ribeiro Carrão
(Catarina Carrão)

 

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Customer Reviews: