Products and Services
COREALIS Professional Services
Source:
Ropack, Inc.
COREALIS Pharma recognizes the uniqueness of each Client and their projects. Frequent communications, interactions, and follow-ups with clients are of the utmost importance. Clients will have the possibility to access in real-time the information, the data, and the documents related to their projects via a secure electronic link
COREALIS Pharma recognizes the uniqueness of each Client and their projects. Frequent communications, interactions, and follow-ups with clients are of the utmost importance. Clients will have the possibility to access in real-time the information, the data, and the documents related to their projects via a secure electronic link. Maintaining appropriate contacts with Clients and providing them with a maximum amount of information on the progress of each project is essential to ensure success. COREALIS Pharma assists during various steps of the development or manufacturing of the product by offering professional consulting services and support with regulatory agencies at the required time and location.
Services
- Consulting service for interactions with external laboratories and regulatory agencies
- Transfer of processes and analytical methods
- Manufacturing of development troubleshooting
- Optimization of formulations, processes, and analytical methods
- Product development strategies
- Formulation and process equivalence strategies according to SUPAC guidelines
- Regulatory support for submissions in the United States, Canada, and Europe
- Preparation in CTD format of the CMC section for submission to Canadian, European and American regulatory authorities.
- Classification of molecules according to the BCS (Biopharmaceutics Classification System)
- Interpretation of TPD, FDA, and ICH guidelines
- Support in development project management
- Support and management of clinical trials
