The development and growth of the generic pharmaceutical industry over the past 25 years has come as a response to rising healthcare costs. Generic pharmaceuticals, which are carefully manufactured formulations of the original patented “brand name” products, help to make healthcare more affordable.
Chanelle Medicaldetermines its R&D strategy based on the latest medical needs. They are able to forecast future ethical products that will enter the market as far as 8, or more, years ahead of patent expiry. They then identify leading candidates to develop as generics.
We have over 800 product licenses granted to date with the Chanelle Medical experienced in-house R&D Quality and Regulatory Affairs Teams. All were developed in-house, or with the assistance from our development laboratory in Amman, Jordan.
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.
Our team of 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, guideline, 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