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
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
- Licensing-in & Licensing-out
- Acquisitions and mergers
- Product portfolio gap analysis
Project Management
- Regulatory development
- Manufacturing, GMP compliance
- Product development
- Clinical development
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© 2014 Sindor Healthcare. All rights reserved.
