Operational support for Pharmaceutical industry and Biotechnology.Services and roles:- Global or specific GMP support according to needs and situation.- Internal and third parties audits.- Interim Manager.- Qualified Person, Pharmacien Responsable Intérimaire (France).

Field of activities : Manufacture of investigational ATMP (sterile cell-gene therapy products) (phase I II)Quality Control Department: installation, qualification ; team hiring and management : 4 technicians, 1 manager ; organization and quality documentation ; preparation to methods transferClean room environmental monitoring viable and non-viables particles In clean rooms grade D to A: EMOQ, EMPQ, risk analysisDesinfectants studies Subcontractors handlingMaterials and Raw materials : criticality analysis and control at receipt definitionCorporate external audit for manufacturing site for DP importationPharmaceutical site ANSM Authorization obtention ANSM Annual statement (Etat des lieux)

To support companies which want to scale up and consolidate their pharmaceutical status, through pragmatic and adapted expertise, to allow timelines and investments optimization.Focus on the pharmaceutical quality system: quality assurance and GMP compliance.

Fields of activities: Biotechnology – Pharmaceutics - QC testing services delivery - DP Manufacturing, cells and viral banks manufacturingDrug Product certification : batch review and releaseGMP ANSM Authorization and Certification obtention ; inspection handling and replies to ANSM issuesANSM Annual statements (Etat des lieux)Quality Control department: Analytical results review for certification of analysis ; team management : direct line 15 employees (Pharmacists and QC managers) among 30-35 (Operational managers, analysts, qualification/validation technicians)Internal and external (QC vendors) Quality Auditor Member of “Bioproduction Quality Group” - LEEM “Les Entreprises du Médicament”

Field of activities : Preclinical testing services delivery / In vitro assays / Good Laboratory Practices QA team management : 1 Quality Assistant, 1 MetrologistRenewing GLP certificationInternal project lead: source data digitization and electronic archival

Preclinical testing services delivery / In vitro assays ISO 9001 certification: preparation, audit handling, certification and follow-upInternal Quality Auditor

Clinical development (GCP) Pharmacovigilance (Good Pharmacovigilance Practices) Sales forces (under quality Certification according to French regulation)

Field of activities : ATMP manufacturingISO 9001 certification renewing and follow up (UTCG)Relationships with health authorities and legal aspects Hospital internal Quality Auditor

Home-basedField of activities : Clinical development Phases II trials in oncology (prostatitis, stomach, brain), hematology (GvHD), cardiology (cardiogenic shock)Phases III trials in oncology (bladder, kidney)Monitoring activities & Project manager for phases I

Field of activities : Clinical trials sponsoringCreation of the office organization and management: 1 expert clinician, 2 CRAs, 1 assistantProjects budgets follow-up, coordination between administration and clinicians Coordination of experts committees Relationships with Health Authorities

Biological and toxicological studies in closed environments for spatial activitiesParticipation to the European Space Agency (ESA-ESTEC) parabolic flight campaigns (1989-1990)