Our Expertise

Regulatory Affairs
  • Consultancy on Regulatory Strategy
  • Support in preparing dossiers in ICH CTD, CSDT or other
    formats to meet health authority requirements for Medicinal
    Products, Medical Devices, Biologicals, Biosimilars and
    other healthcare products.
  • Submission and follow-up with applications.
  • Product licence holding and protection

Marketing & Communications
  • Joint venture with TNBT Asia to deliver Pharma creative
  • Copywriting
  • Promo material screening for marketing code compliance

Quality Management Systems
  • Consultancy to meet with ISO Standards including ISO 9001:
    2008 and ISO 13485
  • Consultancy to meet GDPMDS (Medical Devices, Singapore)
  • Consultancy to meet GDPMD (Medical Devices, Malaysia)
  • Consultancy to meet GDP and GMP requirements
  • Consultancy in meeting CE requirements

Business Development & Product Portfolio Enrichment
  • Licensing-in & Licensing-out
  • Acquisitions and mergers
  • Product portfolio gap analysis

Project Management
  • Regulatory development
  • Manufacturing, GMP compliance
  • Product development
  • Clinical development
Sindor Healthcare Consulting
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