Development
Full-service Development: development, validation, transfer, stability
Megaren Innovation & Development center.
For more than 7 years, we are working with a panel of customers, researchers, physicians, scientists, pharmacists, from public institutions, start-ups, and small, medium and big pharmaceutical companies. Our scientific and technical expertise allow us to manage Pharmaceutical Development combining Galenic Formulation and Analytical Support starting from early stages developments, clinical trial phases, to commercial manufacturing. Megaren is the ideal partner to support the manufacturing of small batches for Clinical Trials.
For more than 7 years, we are working with a panel of customers, researchers, physicians, scientists, pharmacists, from public institutions, start-ups, and small, medium and big pharmaceutical companies. Our scientific and technical expertise allow us to manage Pharmaceutical Development combining Galenic Formulation and Analytical Support starting from early stages developments, clinical trial phases, to commercial manufacturing. Megaren is the ideal partner to support the manufacturing of small batches for Clinical Trials.
Our way of thinking and working
Highly skilled multi-specialty project managers dedicated to clients’ R&D to commercial programs
- Development strategy focused on risk management and quality, using QbD (Quality by Design) approach
- Secure, cost efficient solutions using Design of Experiments (DOE)
- Highly qualified multi-disciplinary technical team
- Advanced, efficient, cost-effective process and analytical tools
Specializing in contract manufacturing, Megaren ensures that its innovative galenic forms remain competitive, practical and easy to use for the patients. The development of those galenic formulations for pharmaceutical use aims to improve the lives of patients and doctors.
Analytical testing constantly assesses the product quality from development to final release.
Our team comprises analytical experts using regularly maintained, updated, and qualified equipment to perform the following services:
- Analytical Methods Development and Validation
- Analytical Methods Transfer
- Storage in ICH and stability testing
- Extractables / Leachables risk analysis
- ICHQ3D guideline risk analysis
- Nitrosamine risk analysis
- Cleaning validation