OFFERING THE TOTALITY OF DEVELOPMENT
- PROJECT PLANNING
- CANDIDATE SELECTION
- DUE DILIGENCE
- FEASIBILITY
- BUDGETING
- CMO SELECTION
- COMPLETE DEVELOPMENT OF A BIOLOGIC OR BIOSIMILAR IN A COST SAVING VIRTUAL WAY
- CLONING
- PILOT PROCESS DEVELOPMENT
- SCALE UP
- ANALYTICAL MEHTODS
- DRUG PRODUCT PLANNING, LOGISTICS, PROVIDERS
- PATENT STATUS EVALUTATIONS
- BIOANALYTICAL
- REGULATORY AFFAIRS - EARLY PHASES
- PHASE I CLINICAL
- PROCESS VALIDATION
- GMP MANUFACTURING
- PHASE III CLINICAL TRIAL - STRATEGY, PLANNING, CRO SELECTION, MANAGEMENT, CLOSE-OUT
- REGULATORY AFFAIRS - DOSSIER PREPARATION, INTERACTION WITH FDA, EMA ETC.
- LAUNCH PREPARATION
- Biopharmaceutical Manufacturing Facility Planning and Implementation
- BIOPHARMACEUTICAL AND BIOSIMILARS TRAINING COURSES
