Our Services
Comprehensive pharmaceutical regulatory and manufacturing services for global market success
Complete Pharmaceutical Solutions
From regulatory compliance to manufacturing excellence, we provide end-to-end pharmaceutical services
Regulatory Support
Complete regulatory compliance services to ensure smooth market entry and continued compliance across global markets.
Manufacturing Excellence
State-of-the-art manufacturing facilities with capacity for pharmaceuticals, APIs, nutraceuticals, and medical devices.
Global Distribution
Extensive distribution network covering 20+ countries with reliable supply chain management and logistics support.
CTD/eCTD Submissions
Expert preparation and submission of Common Technical Documents (CTD) and Electronic Common Technical Documents (eCTD) for regulatory authorities worldwide.
- Module 1 preparation for region-specific requirements
- Quality, non-clinical and clinical documentation
- Electronic publishing and validation
Regulatory Expertise
8+ years of experience in regulatory submissions across multiple global markets
Dossier Preparation
Comprehensive dossier preparation services for new drug applications, including quality dossiers, bioequivalence studies, and clinical documentation.
- Quality dossier compilation and review
- Bioequivalence and clinical study reports
- Risk management and pharmacovigilance plans
Documentation Excellence
Meticulous preparation of all regulatory documentation with quality assurance
Stability Reporting
Comprehensive stability testing and reporting services to support shelf-life determination and regulatory submissions.
- Long-term and accelerated stability studies
- Statistical analysis and shelf-life prediction
- ICH guidelines compliance
Quality Testing
Advanced analytical testing facilities with validated methods and protocols
ACTD Registrations
ASEAN Common Technical Document (ACTD) preparation and registration services for Southeast Asian markets.
- ASEAN market entry strategies
- Local regulatory liaison services
- Post-approval maintenance and updates
ASEAN Expertise
Specialized knowledge of Southeast Asian regulatory requirements and processes
Third-Party Manufacturing
Complete contract manufacturing services with state-of-the-art facilities and quality assurance systems.
- Tablets, capsules, and liquid formulations
- API manufacturing and purification
- Custom packaging and labeling
Manufacturing Excellence
WHO-GMP certified facilities with capacity for diverse pharmaceutical products
Success Story
How we helped a pharmaceutical company achieve global market entry
Global Generic Drug Launch
We partnered with a European pharmaceutical company to launch their generic cardiovascular medication in 15 countries across Asia and LATAM. Our comprehensive regulatory and manufacturing support enabled rapid market entry with full compliance.
Services Provided:
- CTD/eCTD preparation for all markets
- Bioequivalence study coordination
- Manufacturing and supply chain setup
- Local regulatory liaison
Ready to Get Started?
Contact us today to discuss how our services can help your pharmaceutical business succeed globally.