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 communications
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