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Formulation and process development
- Process development and optimization
- Development of analytical methods
- Validation of analytical methods
- Validation of manufacturing process

Quality and compliance
- Laboratories on site
- Chemistry and microbiological
- Analytical method development and validation
- Stability testing programs
- Technology transfer
- CMC documents and CTD support

Commercial batches
- Scale-up to commercial
- Cytotoxic, high potency sterile products (vials, ampoules, and prefilled syringes)
- Solid dosages (tablets and capsules)
- Site transfer and validation process
- Lyophilization
- Packaging and labeling

Pre-clinical and clinical batches
- Drug development, formulation and scale-up
- Lyophilization cycles development
- Complete clinical manufacturing (Phase I to Phase IV)
- Clinical trial sterile manufacturing & filling of vials and pre-filled syringes
- Clinical trial solid dosage manufacturing of tablets and capsules
- Placebos
- Release testing
- Packaging and labeling of blinded and open label materials

Storage capabilities
- Controlled temperature rooms
- Walk-in refrigerators
- Walk-in freezers
- GMP