Translating Complex Science into the Real-World.

 Creative thinking at your service!

A critical aspect for certification, or for an effective Medical & Biotechnology marketing, is a language that any scientific or technical regulatory professional would find valid, while still being accessible and understood by all people.

Our objective at BioSciPons is to help manufacturers put safe and effective medical products into the market by simplifying the language used, whether in a brochure or in technical report or regulatory submissions.

We are experts at Translating Complex Science Into the Real-World.

BioSciPons works from any starting point for a customised service. 

Personalised services to the needs of each individual project. 

• Clinical Evaluation Reports (CERs): Medical Devices (MDs) (e.g, EU MDR Notified Bodies, Health Canada, MHRA UK,...)
  

• FDA 510(K) submissions: Equivalence-based, De-Novo, Abbreviated & eSTAR (electronic submissions)

• Summary of Safety and Clinical Performance (SSCP): Health-professional/user & Patient lay summary

• State-of-The-Art (SoTA): What is established & What are the trends in your MedTech device field

• Clinical Literature Reviews (MDR 2017/745 & IVDR 2017/746): PRISMA evidence-based Systematic Reviews

• Science blogs with undercover science marketing concepts
  
• Clinical Technical reports (Investigator Brochure, Clinical Study Report, etc.)
• Book chapters/eBooks

• Press releases, ...

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

Expertise: 
- High-risk devices Class III (e.g., Cardiac & Endovascular implants)
- AI/ML Software as Medical Device (AI/ML SaMD in e.g., Cardiology, Radiology, In vitro Diagnostics,...)
- Cosmetics & Aesthetics (e.g., Injectables)
- Innovative therapies (e.g., psychedelic compounds like psilocybin)
- Biologics & Biosimilars
- Advanced Therapy Medical Products (ATMPs)
- Novel Foods (e.g., cell culture-based meats)...

About:

I'm Catarina Carrão, the founder of BioSciPons and I'm personally involved in each project.

I did a PhD in Biochemistry and worked in academic research for more than 15 years in different international institutions (e.g., Yale University, Universitätsmedizin Charité). 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 in the 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 member of the Regulatory Affairs Professional Society (RAPS), and a delegate of The Organization of Professionals in Regulatory Affairs (TOPRA) - 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; and 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.

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: 

      contact@bioscipons.com

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

https://www.linkedin.com/in/catarinacarrao

Selected customers:

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 medical and biotechnology manufacturers in different fields.

Customer Reviews: