Partnership
Design, Evaluation, Pre -Clinical & Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine
- Consulting
CEO & Managing Director
PKNM Solutions Sàrl
Colombier (VD), Vaud, Switzerland
Niche Consulting Firm on Pre -Clinical Development, Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine
· 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
Skills
Interests
Partnership
Design, Evaluation, Pre -Clinical & Clinical Development, Medical & Regulatory Affairs and Translational Applied Medicine