• In-house product development team for injectable formulations.
• Formulation and process development incorporating Quality by Design (QbD).
• Quality standards establishment, method development and validation, compatibility studies and stability studies.
• Clinical, Validation & Registration batches.
• Rich experience in EU and US FDA GMP requirements for contract manufacturing.
• Dedicated, flexible technical team for efficient product tech-transfer.
• Established tech-transfer process, completed numerous international tech-transfer projects.