IMP Department Services at Basic Pharma
The Investigational Medicinal Product (IMP) department at Basic Pharma provides essential support for companies in drug development, specializing in Investigational Medicinal Product manufacturing and regulatory compliance. As a CDMO pharma (Contract Development and Manufacturing Organization), the department's activities focus on CMC Pharma (Chemistry, Manufacturing, and Controls) to facilitate the path of investigational products to clinical trials.
Core Services: Manufacturing and Supply
The department’s work in Investigational Medicinal Product development and manufacturing is grounded in regulatory compliance and scientific rigor, offering a streamlined suite of services critical for new drug candidates.
- GMP Manufacturing: The cornerstone of operations is GMP Manufacturing. Facilities are designed and run in strict accordance with GMP (Good Manufacturing Practice) guidelines. This standard applies to all processes, from raw material selection to the final product release. The objective is to produce Investigational Medicinal Products that are consistently safe, effective, and of high quality, thereby protecting both the patient and the integrity of clinical data. Experience with various dosage forms, including solids, liquids, and semi-solids, allows for a wide range of Investigational Medicinal Product project support.
- Clinical Trial Supply Management: The logistics of a clinical trial are handled through comprehensive supply management services. This includes packaging, labeling, randomization, storage, and global distribution. Systems are in place to ensure clinical trial sites receive the correct Investigational Medicinal Product in the right condition and on time. The department is also experienced in managing the logistics for temperature-sensitive Investigational Medicinal Products and navigating the diverse international regulations that govern clinical trial materials.
The Role in Manufacturing Pharma
The role in manufacturing pharma is to offer a reliable, transparent, and expert service. Each Investigational Medicinal Product project is treated as unique, with a focus on providing a flexible and responsive partnership. A collaborative approach and clear communication ensure project owners are fully informed throughout the process. The goal is to provide a solid Investigational Medicinal Product manufacturing foundation, allowing clients to focus on other critical aspects of their drug development programs.