Since it was founded in 1995, WHITE-TILLET has set itself apart by combining genuine expertise in the evaluation and regulation of both Medicinal Products and Medical Devices.

OUR EXPERTISE

• QUALITY

  • Implementation of ISO 13485 MD Quality Management System
  • ISO 13485 or ISO 9001 quality audits
  • ISO 14155 clinical audits
  • Preparation for and assistance during Notified Body audits

• DESIGN/DEVELOPMENT

  • Advice and execution of development/design plans: quality, non-clinical and clinical (including clinical trial design)
  • Development plan: budgets and road map

• MARKETING

  • Medicinal Products MA dossiers (including clinical modules)
  • MD/IVD technical documentation in accordance with MDR/IVDR and MDD-IVDD/MDR-IVDR gap analysis
  • Dossiers for MD intended to administer a medicinal product
  • MD: Expertise of biosafety (BRA) and clinical data evaluation (CER) reports
  • IVD: Expertise of performance evaluation reports
  • Assistance with MA or CE marking procedures

• MARKET ACCESS

  • Dossier and reimbursement procedure (medicinal Products or MD – FR and EU)
  • Advice on and assistance with price negotiations

• POST-MARKET (MD)

  • PMS/PMCF and Risk Management Plans (including IAU) for MD or IVD
  • Assistance with MD vigilance and IVD vigilance
  • Advice on advertising (including the use of clinical data)
  • Regulatory assistance in the event of a serious incident or dispute with the authorities
  • Regulatory watch

• INTERNATIONAL

  • Regulatory assistance in the UK, EU, USA and China
  • Product regulatory positioning and associated regulatory roadmaps
  • Agency meetings and notified bodies interactions

• IFEP (INSTITUTE OF TRAINING IN HEALTH PRODUCT EXPERTISE) INTER- AND INTRA-COMPANY TRAINING DIVISION

  • MD/IVD, Combination Products
  • Medicinal Products, MD intended to administer a medicinal product
  • Advanced therapies

OUR AREAS OF ACTIVITY

Medical Devices, Medicinal Products (including Bilogics), Combination Products (MD/Medicines), IVD, Innovative Therapies

OUR STRENGTHS

• Over 25 years of dual expertise in Medicinal Products and Medical Devices
• Strong in-house expertise combined with a wide network of collaborating Experts
• Portfolio of over 200 pharmaceutical and Medtech clients
• Research Tax Credit (RTC) approval
• QUALIOPI certified training organisation