OUR SERVICES

Services for Licensing

• Comprehensive support for in-licensing and out-licensing activities
• 15+ years of combined team expertise in pharmaceutical deal-making
• Global network to identify and engage strategic partners
• Opportunity scouting, asset evaluation, and due diligence
• Deal structuring, negotiation, and alliance management
• Focused on maximizing asset value and long-term growth

Manufacturer Identification Services

CMO and CDMO Manufacturer Sourcing

• Identification of reliable CMOs/CDMOs for drug development and production
• Capability evaluations for small-molecule, biologics, and specialty products
• GMP-compliant facilities for API and finished dosage manufacturing
• Negotiation support for cost-effective partnerships

API (Active Pharmaceutical Ingredient) Sourcing

• Identification of high-quality API manufacturers globally
• Supplier assessment for regulatory compliance (Health Canada,US FDA, EMA, WHO-GMP)
• Support in API documentation (DMFs, CEPs, CoAs)

Finished Dosage Form (FDF) Manufacturers

• Selection of partners for solid, liquid, injectable, and specialty formulations
• Verification of compliance with regulatory and quality standards
• Assistance in contract negotiation and supply chain management

Services Portfolio Planning

• Strategic planning for pharmaceutical service offerings
• Market analysis and competitive benchmarking
• Identifying key therapeutic areas and growth opportunities
• Regulatory compliance and commercialization strategy
• Business model optimization for cost efficiency

RLD (Reference Listed Drug) Sourcing

• Global sourcing of innovator (RLD) drugs
• Verified procurement from authorized suppliers
• Documentation support for regulatory filings (DMFs, ANDAs, etc.)
• Import/export logistics and customs clearance management

Pharmaceutical Regulatory Support

• Guidance on FDA, EMA, and global regulatory requirements
• Preparation of submission dossiers for drug approvals
• Support for bioequivalence (BE) studies and clinical trials
• Post-approval regulatory compliance services

CMC (Chemistry, Manufacturing & Controls) Consulting

• Development of comprehensive CMC strategies for regulatory submissions
• Method development, validation, and tech transfer support
• Audits, risk assessments, and compliance monitoring
• GMP compliance and quality management systems