We can work with you to overcome even the most complex challenges, ranging from improving patient compliance to expanding indications.
Our partner team can support novel formulation development or generic substitution.
DOSAGE FORMS / LICENCING
Track record is one you can trust. Finished dosage form development team has successfully created numerous control release and extended release formulations, successfully ensuring afterward rapid scale up to full production. Supports customers in developing:
- Tablets (bilayer, film coated, effervescent, chewable)
- Hard gel capsules
- Soft gel capsules
- Multiple unit systems (microspheres, pellets)
Capabilities
Finished dosage form development services include:
- Galenic development (screening, pre-formulation and lab scale development)
- Analytical method development, verification and validation
- Stability testing
- Production and release of clinical trial material (investigational batches)
- Product transfer
- Process validation
- Preparing registration dossiers and manufacturing documentation
- Experience in drug marketing authorisation in many countries