Turnkey API & Formulation Development
Comprehensive end-to-end solutions from concept to commercial success
Accelerate Your Path to Market
Our integrated approach combines expertise in API development, formulation science, and regulatory strategy to deliver complete solutions that streamline your product development journey.
Custom API & Formulation Development
From molecule selection to optimized API & formulation, we deliver tailored solutions that meet your specific requirements and target product profile.
- Comprehensive API characterization and optimization
- Formulation development for various dosage forms
- Analytical method development and validation
- Stability studies and forced degradation
- Process optimization and scale-up support
- Compatibility studies and excipient selection
Regulatory & Compliance Support
Navigate complex regulatory landscapes with our expert guidance on global requirements from FDA, EMA, and other regulatory authorities.
- Regulatory strategy development and gap analysis
- CMC documentation preparation and review
- Regulatory submission support (IND, IMPD, NDA, ANDA, etc.)
- Regulatory agency interaction and meeting preparation
- GMP compliance assessment and remediation
- Quality system implementation and improvement
Scale-up & Tech Transfer
Ensure smooth transition from lab-scale to commercial production with our comprehensive scale-up and technology transfer services.
- Process scale-up strategy and implementation
- Risk assessment and mitigation planning
- Technology transfer protocol development
- Equipment qualification and process validation
- Knowledge transfer and training
- Troubleshooting and process optimization
Manufacturing & Commercialization Support
End-to-end assistance in commercial launch, supply chain management, and lifecycle optimization to ensure long-term success.
- Commercial manufacturing strategy development
- Supply chain optimization and management
- Continuous improvement programs
- Post-approval changes and lifecycle management
- Market expansion support
- Cost optimization strategies
Customer Benefits
Single Partner from Concept to Market
Eliminate handoffs between multiple vendors and enjoy seamless project management with a single, accountable partner throughout your product's journey.
Faster Time-to-Market with Regulatory-Ready Solutions
Accelerate development timelines with our integrated approach that anticipates regulatory requirements from the start, reducing rework and delays.
Seamless Integration Across Development Stages
Benefit from smooth transitions between development phases with teams that communicate effectively and share knowledge throughout the process.
Global Expertise & Compliance Assurance
Access deep expertise in international regulatory requirements and quality standards, ensuring your products meet compliance expectations worldwide.
Ready to Accelerate Your Product Development?
Contact our team of experts today to discuss how our turnkey solutions can help bring your pharmaceutical products to market faster and more efficiently.
Contact Our Experts