Research & Development Services
Innovative formulations designed for global compliance and commercial success.
Dosage Form Expertise
- Injectables: Depot, RTU, nanosuspensions, emulsions
- Ophthalmic: Solutions, suspensions
- Oral Solids: IR, ER, MUPS, multilayer, pellets
- Oral Liquids: Solutions, suspensions, paediatrics
Core Services
- Pre-formulation & formulation development
- Analytical method development & validation
- ICH stability studies
- Exhibit batch & scale-up support
- Tech transfer documentation
Flexible Engagement Models
- Fee-for-Service: Milestone-driven, transparent costs
- Co-Development: Shared risk, shared IP/commercial rights
- Differentiated formulations
- 505(b)(2) strategies
- Lifecycle extensions & repurposed assets
Manufacturing & Tech Transfer
- Scale-up & exhibit batch oversight
- Process validation (protocols & reports)
- Tech transfer packages for CDMOs/CMOs
Drug Product (Formulation)
- Pre-formulation & excipient compatibility
- Formulation & process development (injectables, orals, ophthalmics)
- Container-closure systems & E&L studies
Analytical & Quality
- Method development & validation
- Dissolution/discriminatory methods
- Forced degradation & stability-indicating assays
- ICH stability studies & reporting
