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Quality and Regulatory in Life Sciences
Products & Services
Regulatory Affairs
border
Signifix has expertise and can provide consultancy services in
the following areas:
  • Design and implementation of global regulatory strategies for (bio)medical products, advanced therapy products market access in USA, EFTA countries, Asia, Canada, Middle East, South and Latin America
  • Defining global product development plans and programs
  • CE mark for all classifications of medical devices (Medical Device Regulation 2017/745 (MDR), including combination devices with ancillary medicinal substances and animal/human tissue and medical mobile applications (apps)
  • Import license/ export license for human tissue products (hTEP)
  • ATMP scientific advise processes Gap analysis and implementation of EU Tissue and Cells Directives Directive (2004/23/EC, 2006/17/EC and 2006/86/EC) for human tissue establishments
  • Lobbying with local authorities, European Commission
  • Providing the European Authorized Representative (EAR) services according to 2007/47/EC
  • Defining or evaluating pre-clinical testing programmes
  • 510k, PMA, IDE, IND, BLA applications
  • Orphan drug routes, compassionate use or humanitarian device exemption routes
  • Regulatory dossiers to start clinical studies in the EU and US (CTD including IMPD's)
  • Providing the responsible person services according to 2004/23/EC, 2006/17/EC and 2006/86/EC
  • Due diligence, assessment of the feasibility of product development pathways and regulatory strategies
  • Interim management of regulatory affairs departments
  • Training and coaching: customized RA training programmes for individuals and groups