R&D
Research & Development
At Chanelle Pharma, our in-house research and development capabilities are the cornerstone of our success and continued growth. As a generic medicines provider, our commitment to innovation is comparable to brand leaders in the industry.
Chanelle’s R&D laboratories in Ireland and Jordan include more than 70 scientists who innovate every day to develop and licence products in the Human and Animal Health market.
Our focus and commitment to R&D has allowed us to register over 5000 licenses in countries all over the world. Our R&D laboratories are equipped with the latest in R&D technology and highly competent and qualified staff who continuously engage in research studies and experiments to develop safe and effective medicines.
Our R&D Capabilities include:
- Product synthesis
- Formulation development: solutions, suspensions, powders, tablets & capsules including slow release formulations
- Process Validation: pilot scale batches
- Stability studies: protocols compiled according to ICH Guidelines
- Bio equivalence studies: monitor & write Expert Reports
- Registration dossiers: according to CTD format
- Process Validation: commercial scale batches
- Packaging of product
- Consultancy service
- Analytical development and validation
Regulatory Affairs
The registration of any new product incorporates the generation of detailed pharmacological, toxicological, safety and efficacy data for the product. At Chanelle, we have an excellent registration team who have had consistent success in registering products all over the world.
Chanelle Pharma is a HPRA (Health Products Regulatory Authority) licensed company for the manufacture of medicines licenses. Our Regulatory Affairs department offers our partners and clients worldwide regulatory assistance with:
- Compilation and submission activities of Marketing Authorisation applications through the most appropriate regulatory submission pathway
- Expert Report writing, pharmacovigilance, variations, renewals etc.
- Management of bio-equivalent studies, protocol approval and expert report preparation
- Support to overcome critical regulatory and quality hurdles
