Croatian-Swiss Partner Search for Eurostars

12 Mar 2023 – 10 Mar 2024

Petros Malitas

CEO & Managing Director

PKNM Solutions Sàrl

Colombier (VD), Vaud, Switzerland

3 profile visitsBioTech

Niche Consulting Firm on Pre -Clinical Development, Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine

My organisation

PKNM Solutions Sàrl

PKNM Solutions Sàrl

Colombier (VD), Switzerland

PKNM Solutions’ Team will act as an innovation incubator for Swiss and European startups. The Company will invest and develop in prototypes and product ideas emerging from research areas aiming at forming a bridge between the research project and the first product launch. We shall develop the core team and initial product within a supportive business unit for a proper development, which can lead to success. Our experts are seeking to give birth to and nurture new businesses, which will forge their own paths of innovation leadership. Our target is to develop systems within which webs of innovative businesses may prosper. We aim to accelerate the slow pace of innovation from European research with a more daring approach and by Bridging the Gaps Integrate it with the advancements of Asia and USA. Obviously certain intelligent risks are taken but well within the bounds of safety, responsibility and sustainability
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About me

·      Design / Evaluation, / Implementation and Due Diligence of Translational Projects

·      Pre-Clinical Development / Animal Studies, Computational Studies, In Silico Verification + Validation

·      CLINICAL DEVELOPMENT Clinical Studies fir most of the major Therapeutics Clusters based on CGPs Globally

·      MEDICAL AFFAIRS Medical Evaluation and Medical "Sponsoring" / Entrance to the Market

·      REGULATORY AFFAIRS

·      ISO 9001,

·      ISO 13485:2016,

·      ISO 62304 / IEC 62304 Medical Devices Software

·      ISO/DIS 14971:2018: Application of Risk Management To Medical Devices

·      Biocompatibility; ISO 10993, USP

·      Cytotoxicity; ISO 10993-5, USP

·      Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745

·      ISO 27001 & GDPR and

·      MDD / MDR

·      IVDD / IVDR

·      CE Mark for Class I, IIa, IIb and III & FDA Clearance(s)

·       ISO/IEC 17024:2012: Personnel Certification is popular to harmonize the personnel conformity assessment process worldwide

My organisation

PKNM Solutions Sàrl

Skills

  • QA
  • Regulatory Affairs
  • Medical Affairs
  • Entrance to the Market
  • Verification & Validation
  • Safety
  • Certification
  • Audits' Support
  • Clinical development
  • Risk Analysis
  • Risk Management
  • Post Market Follow Up
  • Post Market Surveillance
  • Translational Medicine
  • testing

Interests

  • Innovation in Medical Technology
  • Medical Devices
  • IVDs
  • pharma
  • Cell & Genetic Treatments
  • biotechnology

Marketplace (1)

  • Partnership

    QA & Regulatory Development

    Design, Evaluation, Pre -Clinical & Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine

    • Consulting
    Author

    Petros Malitas

    CEO & Managing Director at PKNM Solutions Sàrl

    Colombier (VD), Vaud, Switzerland