QA & Regulatory Development

Niche EXPERTISE:

·      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