At FicusRealtime, we provide comprehensive formulation development services to help pharmaceutical and biopharma companies design, optimize, and validate drug products that are safe, effective, stable, and regulatory-compliant.
Our Formulation Expertise Covers:
Pre-Formulation Studies:
API compatibility & physical-chemical characterization
Excipient selection and interaction studies
Solubility, stability, and degradation profiling
Formulation Design & Development:
Prototype development for various dosage forms:
Tablets, capsules, injectables, suspensions, topical & oral liquids
Optimization of drug release, bioavailability & patient compliance
QbD (Quality by Design) integration for robust process development
Process Optimization & Scale-Up:
Lab to pilot-scale formulation transition
Equipment mapping and critical process parameter (CPP) identification
Batch reproducibility and cost-effective scale-up strategies
Regulatory & Documentation Support:
Development reports and technical justification documents
Stability studies as per ICH guidelines
Dossier support: ANDA, NDA, CTD submissions
Regulatory gap assessment and audit readiness