We are experts at translating complex science and regulations to the Real-World: we bridge the gap between science and people, manufacturers and regulators.
A bridge between two worlds.
BioSciPons works at the interface of regulatory and medical affairs.
We translate complex science into precise, clear regulatory and medical knowledge: Clinical Evaluation Reports, Systematic Reviews, Technical files, Investigator Brochures, Medical Journal Manuscripts, Whitepapers, IFUs, Manuals, Brochures, workshops…
Our aim is to explain the relevance of a medical technology product, while maintaining regulatory compliance and scientific acumen.
We bridge the gap between medical R&D, regulatory agencies, healthcare systems and users/patients.
To cross this bridge two things are needed:
(1) A high level of science communication,
(2) A deep understanding of regulations, compliance, medical technology and biotechnology.
As clinical scientists and regulatory affairs experts, we understand the complexity of the details.
As communicators, we transform complex clinical data and translate it into consistent, clear information. This information is tailored to each target audience (e.g., regulators, notified bodies, medical journal peer-reviewers, board executives, clinicians, users / patients).
Research services: We find gaps in clinical evidence aligned to global regulatory standards and prepare the clinical development plan of the medical technology product for regulatory compliance.
We guide you through market authorisation and market access.
BioSciPons works from any starting point for a personalized service to fit the needs of each individual product.
Focus: Medical Devices Class IIa, IIb & III; In Vitro Diagnostics (IVDs); Digital Health: SaMD / MDSW / Artificial Intelligence; No medical purpose; in silico / simulation studies.
Providing services in clinical development, regulatory compliance, regulatory submission, medical writing, and science communication.
Company Details
- Founded
- -
- Address
- Vienna, At
- Industry
- Research Services
- NAICS
-
Scientific Research and Development ServicesResearch and Development in the Physical, Engineering, and Life SciencesResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Website
- https://www.bioscipons.com
- HQ
- Vienna
Bioscipons Questions
Bioscipons's website is https://www.bioscipons.com
Bioscipons's LinkedIn profile is https://at.linkedin.com/company/bioscipons
Bioscipons's industry is
Research Services
Bioscipons's top competitors are
Tricopat Global,
3r Lifescience Gmbh,
Manibus Health,
Slg Prüf- Und Zertifizierungs Gmbh,
Br Quality Consulting Gmbh,
The Text Clinic,
Arterioscope,
Sitem-Insel School,
Avicenna Alliance,
Novineon Cro Gmbh.
Bioscipons's categories are Research Services
Bioscipons's founding year is 2016
