Drug Product Development Excellence
Advanced CRO services from feasibility to IND-enabling studies. Accelerate your pharmaceutical development with our scientific expertise and state-of-the-art facilities.
184,000 Sq ft
R&D Campus
350+
Fume Hoods
ISO
Controlled Labs
Our Comprehensive Services
Feasibility Studies
Exploring formulation possibilities with confidence through comprehensive preformulation analysis and technical viability assessment.
Our Capabilities:
ISO-controlled labs with 350+ fume hoods
API-excipient compatibility mapping
Solubility profiling and polymorph screening
Early lab-scale batches (100g) for rapid comparison
Final Deliverables:
Data-driven roadmap highlighting key formulation challenges, preferred dosage forms, and optimal scale-up pathways.
Prototype Formulation Designs
From concept to first form - crafting multiple prototype dosage forms to assess performance, properties, and processability.
Our Capabilities:
Design of Experiments (DoE) for optimization
Multiple dosage forms: solids, liquids, injectables
In-vitro testing including dissolution and stability
Lab-scale high-shear granulators and fluid-bed processors
Final Deliverables:
Comparative evaluation of prototypes with detailed compositions, test results, and shortlisted candidates.
Process Development Studies
Building scalable and robust manufacturing processes with comprehensive optimization and regulatory compliance focus.
Our Capabilities:
Pilot-scale reactors and trial equipment (10-100L)
QbD and DoE strategies for design space establishment
Critical process parameter (CPP) identification
Collaborative formulation-analytical integration
Final Deliverables:
Comprehensive process flows, validated protocols, and scale-up strategies ready for tech transfer and GMP manufacturing.
Lead Formulation Selection
Identifying the best fit for clinical advancement through rigorous evaluation of prototype performance and manufacturability.
Our Capabilities:
ICH-compliant stability chambers
Advanced analytical instrumentation (HPLC, UPLC, LC-MS)
Comprehensive data analytics and comparison
Bioavailability and manufacturability assessment
Final Deliverables:
Scientifically justified lead formulation with comprehensive stability and performance data for clinical progression.
IND-Enabling Test Articles
Enabling preclinical success with GLP-compliant materials that replicate intended clinical formulations under stringent conditions.
Our Capabilities:
Cleanroom environments (Class 100,000 / ISO 8)
Small GMP-like batch production
Sterile and aseptic processing capabilities
Complete documentation and CoA generation
Final Deliverables:
High-quality test articles with full documentation including batch records, CoAs, formulation specs, and stability data.
