BIO15PHARMA

Who are we

BIO15PHARMA is a French life-sciences consultancy specialised in quality management, GxP compliance and inspection readiness for pharmaceutical, biotech, medical device, cosmetics, chemical and CRO manufacturers.

Founded in 2021 by Nadjim Mhoma, a quality engineer and former Site Quality Director with 14 years inside major pharmaceutical groups, the company works from one principle: in regulated industries, product quality is what protects patient safety. We build quality systems that pass FDA, EMA, ANSM and ANVISA inspection, lift regulatory injunctions and bring products to market without lost time.

What we deliver

• ISO 9001, ISO 13485, GMP and ISO 22716 certification support, run as a structured programme of 12 expert days over up to 12 months
• GMP, GxP and supplier audits recognised in ANSM, FDA and ANVISA inspections
• ISO 13485, ISO 9001 and GMP readiness and gap audits for medical devices, API, medicament and cosmetic products
• QMS design, simplification and remediation, including the lifting of regulatory injunctions
• Quality process digitalisation: eQMS, electronic batch records, EDMS, Backlog of Deviations, CAPA and computer system validation
• Cleanroom, ZAC and equipment bio-decontamination with the HDM method, to EU GMP Annex 1. HDM technology has helped our clients (Merck, Sanofi, etc.) save more than 22 production days per year
• Biocontamination control training for cleanrooms, on site, remote or e-learning
• Change management and deployment of electronic quality systems (EDM, eQMS, eDDL, eCFR)
• Highly experienced interim manager, Interim quality and compliance managers deployable within 24 hours

Why companies choose us

• A founder with 14 years inside major pharmaceutical groups (Sanofi, Sandoz, GSK, Novartis, Servier, Delpharm, Clarins, Hermès)
• A network of 3,600+ proven interim experts, each with 10+ years in the pharmaceutical industry and life sciences
• Audits recognised in ANSM, FDA and ANVISA inspections, delivered on schedule
• 21 injunctions issued by ANSM, the FDA, and ANVISA that have been lifted
• 875 GxP audits and supplier audits conducted, including 250 conducted internationally (U.S., Canada, Dubai, Senegal, Germany, etc.)
• 480 successfully completed interim management assignments (interim leadership, rapid deployment, crisis management, transformation, remediation, and continuous improvement, etc.)
• 15 specialised divisions spanning quality, regulatory affairs, production, HSE and sterility
• A modular, procurement-ready offer built for public and private tenders
• One aim behind every assignment: product quality that protects patient safety
• Establishment of pharmaceutical sites and subsidiaries, including three subsidiaries based in France