Chanelle Medical evaluates new ethical products entering the market more than 8 years ahead of patent expiry to identify leading candidates to develop as generics.
With Chanelle Medical’s experienced in-house R&D team of 12 people, our Quality team of 30 people and a Regulatory affairs team of 15 people, we have over 800 product licenses granted to date, all developed in-house or with the assistance from our development laboratory in Amman, Jordan (consisting of 20 scientists).
Our R&D team are experts in Product Development;
- Formulation Development: solutions, suspensions, powders, tablets and capsules including slow release formulations
- Analytical Method Development & Validation
- Process Validation: pilot and commercial scale batches
- Stability Studies according to ICH guidelines
- Monitoring of Bioequivalence Studies according to GCP
The annual capacity of Medical development is currently 8 molecules. The whole activity is followed up with full coverage by the company’s Regulatory Affairs Department and later by Launch & Supply Team.
Regulatory Affairs
Our team of 15 regulatory experts focus on
- Dossier submission for marketing authorization of new products, handling of variations and renewal procedures
- Liaison with regulatory authorities
- Compliance of products with the current regulations
- Pharmacovigelence; pre license approval and post license approval
- Continuous monitoring of international legislation, guidelines and customer practices
- Medical Information for the production of labels and patient information leaflets
- Planning and communication with CROs for bioequivalent studies
- Research on new products prior, during and after product development
