BioSciPons is a life sciences communication agency specialised in regulatory affairs and medical writing. 
It bridges the gap between science and people, academia and business,
regulatory agencies and Med&BioTech manufacturers.

A bridge between two worlds.

Services

If your MedTech device needs  market certification
(e.g., EU Notified Bodies, USA FDA, MHRA UK Approved Bodies, Health Canada):
  BioSciPons can prepare the Technical File.

If you need a Workshop to understand the latest MedTech regulatory affairs landscape:
  BioSciPons can do the presentation.

If you need to publish your Post-Market Surveillance Update Report(PSUR) in a simple language:
  BioSciPons can do the medical writing and journal submission.

BioSciPons
Translating Complex Science into the Real-World

Creative thinking at your service!



A critical aspect for certification or effective marketing in the biomedical field is a language that any scientific or technical professional would find valid, while still accessible and understood by everyday people.

Our objective is to help manufacturers put safe and effective medical products into the market by simplifying the language used.

BioSciPons works from any starting point for a customised service.

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BioSciPons delivers customer-specific-made contents tailored to the uniqueness of each device:
  • FDA 510(K) submissions: Equivalence-based, De-Novo, Abbreviated & eSTAR (electronic submissions)
  • Clinical Evaluation Reports (CERs): Medical Devices (MDs) & In-vitro Diagnostic Devices (IVDs)
  • Experience: high risk devices (e.g., Vascular implants), AI/ML Software as Medical Device (SAMD), Cosmetics&Aesthetics, Advanced Therapy Medical Products (ATMPs),...
  • Summary of Safety and Clinical Performance (SSCP): Health-professional/user & Patient Technical File sections
  • 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
  • Post-Marketing Clinical Follow-Up (PMCFgap analysisFind the gaps in your performance studies
  • Post-Marketing Surveillance Update Report (PSUR): Get your PSUR peer-reviewed & published in a indexed medical journal

  • Instructions-for-Use (IFU): Simplify the language in your user manual

  • Workshops (e.g., EU MDR & IVDR, MIRs, FDA...): Let us explain how to get your product certified
  • Patient-Report Outcomes & Surveys: Which questions matter the most to your patients & users

  • Whitepapers: Business-2-Business, Business-2-User
  • Science blogs with undercover science marketing concepts
  • Clinical Technical reports (Investigator Brochure, Clinical Study Report, etc.)
  • Educational products (e.g., book chapters, brochures, manuals
  • eBooks
  • Press releases, ...


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


About:


At BioSciPons, we work with a wide network of scientists from different fields, specially selected for each project at hand (e.g., neuroscientists, vascular biologists, oncologists, geneticists, dermatologists, etc...). This is the only way we can assure the most accurate writing and personalised service for each individual medical product.
 
Catarina Carrão (a.k.a. Ana Catarina Ribeiro Carrão)

Catarina Carrão is the founder and CEO of BioSciPons, which curates each project personally.

She did a PhD in Biochemistry and worked in academic research for more than 15 years in different international institutions (e.g., Yale, Charité). She has authored numerous medical articles and was honoured to receive the European Science Slam award - a testimony of her creativity, enthusiasm and ability to communicate science to lay audiences. She is able to distill complex scientific ideas in a way that is both informative and entertaining.

In 2006, she was a Marie-Curie Early Stage Researcher. In 2013, she was a Fellow of the American Heart Association. And, in 2021 she was nominated Young Science Journalist of the Year by the Association of British Science Writers (ABSW).

Her scientific expertise in neuroscience, cardiovascular, oncology, molecular biology and biostatistics allow her to understand the clinical writing needs of innovative medical device manufacturers; and, support them in navigating the regulatory waters of certification in both USA (FDA) and EU (MDR/NBs). 

She is 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 medical regulatory affairs landscape. 

In 2022, her work "Creativity in Regulatory Affairs" was selected to be presented at the RAPS annual conference. 

She is also an accredited science and medical journalist (World Federation of Science Journalists WFSJ, Medical Journalist Association MJUK), with several authored articles in different media platforms.

Regulatory Science and policy are her 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!


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 MedTech start-ups and big players in different fields (e.g., AI/ML SaMD, ATMPs, Wearables, Implants,...)

Customer Reviews: