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Regulatory Affairs
> Regulatory Intelligence Consultation and Advisory
Our pre-market entry strategy involves much of regulatory intelligence and advisory services provided by our RA consultants, assisting clients who may need vital information for the preparation of a successful dossier, or just to understand the regulatory nuances of the countries of interest. With a decade long experience and local consultants in various countries to offer support in native languages across various product categories, PharmEng breaks cultural barriers to offer a big picture of the regulatory landscape to complete product registration. Such initial regulatory intelligence saves high level executives much precious time to plan their overall strategy for market access.
Services
- Expert advice on Regulatory Strategy
- Marketing Authorization Requirements
- Product classification assessment
- Registration Pathway, Procedures
- Approval Timeline and Fees
- Regulations and compliance requirements
- Preclinical, clinical and CMC requirements
- Documentary and Test requirements
- Due Diligence, Risk and Gap Analysis
- Product lifecycle planning
- GMP and GDP requirements
- Quality Management Systems
- Quality Assurance
- Pricing and reimbursement policies
Countries
- ASEAN: Singapore, Malaysia, Indonesia, Vietnam, Philippines, Thailand, Myanmar, Cambodia
- Asia Pacific: Taiwan, Hong Kong, China, Korea, Australia, New Zealand, India, Bangladesh
