EVALUATION
Experienced Portfolio Team
- Market & trends
- Product idea
- Line extensions
- Project design
PRE-FORMULATION
State-of-the-art facilities
Designing around patents
API
- Literature search
- Risk analysis
- Physicochemical characterization
- Reverse engineering
- API & raw materials in-house development/ sourcing
DEVELOPMENT
Wide range of dosage forms
Modern technologies & equipment
Added value generics development
- Quality by Design (QbD)
- Formulation and process
- Scale up
- Technology Transfer
- Clinical / registration batches
- Stability studies Dossier
MANUFACTURING
GMP pilot facility
Flexible batch sizes
Off-site production experience
- Mass production
- Clinical/registration batches
- Packaging
- Quality assurance
REGISTRATION LAUNCH
Excellent products with CTD/eCTD dossiers (meeting EU, CA, AU, BR, EAEU, CIS & UA requirements)
Day One Launch
- Dossier submission & registration process
- Launch preparation – Process validation PPH or TT to CMO
SUPPORTING SERVICES
- Regulatory affairs
- Intellectual property
- Project management