Drug Product Manufacturing Excellence
From formulation optimization to commercial manufacturing, we deliver comprehensive CDMO solutions across all major dosage forms with robust analytical and regulatory support for global markets.
Multi-ton
Production Capacity
ECTD
Filing Support
GLOBAL
Regulatory Standards
Our Comprehensive Services
Formulation Optimization & Scale-Up
CRAMSN's formulation optimization enhances your lead candidate through systematic QbD methodology, leveraging statistical DoE tools to define scalable design spaces from grams to multi-ton capacity. Quality by design approach targeting critical quality attributes
Dosage Forms Supported
Solid orals & modified release tablets
Sterile injectables & ophthalmics
Multi-layer tablets & pellets
Sublingual formats
Unit-dose liquids
Advanced Infrastructure
High-shear mixers & fluid-bed processors
Coating pans & encapsulators
HPLC, LCMS & PAT analytical tools
Multiscale manufacturing capabilities
Controlled stability chambers
Final Deliverables:
Fully optimized formulation ready for pilot-scale batches
Scalable process flow and preliminary control strategy documentation
Starter stability dataset aligned with regulatory submission requirements
Process Performance Qualification (PPQ)
PPQ validates commercial manufacturing through consecutive production runs under real conditions, proving consistency and reproducibility with full statistical evaluation. Validation of commercial manufacturing process consistency
Validation Approach
Dedicated pilot & commercial GMP suites
Minimum three consecutive batches
Statistical process capability evaluation
Comprehensive yield analysis
Documentation & Controls
High-shear mixers & fluid-bed processors
Protocol templates development
Deviation control strategies
In-process metrics monitoring
Final Deliverables:
Completed PPQ reports affirming process performance and product consistency
Validated batches ready for commercial or exhibit supply
Batch records, analytical certifications, and validation summaries
Technology Transfer & Scale-Up
CRAMSN ensures seamless transitions with clear protocols and knowledge transfer, whether internally or across partner sites, guaranteeing continuity and compliance throughout the process. Seamless transition from development to manufacturing
Transfer Process
Gap assessment & process alignment
Detailed tech transfer dossiers
Equipment mapping & bridging trials
Comparability confirmation studies
Infrastructure & Support
Cross-functional training teams
Integrated scale-up labs (10–100 L)
Kilolabs for early GMP manufacture
R&D, QC, QA stakeholder collaboration
Final Deliverables:
Technology transfer dossier with process parameters and analytical methods
Demonstration batch reports and training protocols
Fully aligned process manuals for commercial launch or site transfer
cGMP Production & Filing Support
GMP-compliant production with regulatory-ready documentation supporting Module 3 filings (eCTD), ensuring alignment with global compliance standards across all major markets. eCTD format regulatory documentation and global compliance
Manufacturing Capabilities
Commercial-scale across all dosage forms
Sterile injectables (vials, ampoules, PFS)
Tablets, capsules & liquid orals
Ophthalmic formulations
Regulatory & Quality
US DSCSA, EU FMD, India DAVA compliance
Packaging & serialization support
Case/pallet traceability workflows
Validated analytical billing & batch release
Final Deliverables:
GMP-grade exhibit or commercial batches ready for regulatory submission
Complete CMC dossier supporting Module 3 (eCTD format)
Batch records, stability summaries,process validation reports, and serialization documentation
