Regulatory Consulting for Pharmaceuticals and Medical Devices
Regulatory strategy and application support for APIs, finished products, and vaccines
Risk classification, pre-market review (QSD/IVD/TFDA applications), and registration for medical devices
Global dossier preparation and regulatory gap analysis (e.g., CTD, CSDT)
Clinical and Drug Development Support
Early-stage strategy development and technology transfer assessment for new drugs
Clinical trial design, monitoring, CRO management, and IRB support
Medical statistics, data management, and clinical study report (CSR) preparation
Customized Regulatory & Project Management Services
Tailor-made regulatory roadmaps and product development strategies based on client needs
Project management integrating R&D, regulatory affairs, quality, and clinical progress
Cross-functional coordination to ensure timely, compliant, and secure execution
One-stop integrated consulting solutions to reduce complexity and communication overhead
Post-Market Surveillance and Quality Systems
Pharmacovigilance (PV) for drugs and post-market surveillance (PMS) for medical devices
Quality Management System (QMS) implementation (e.g., ISO 13485), internal audit readiness
SOP development and regulatory compliance training
