Investigational Medicinal Products (IMP) Department
Basic Pharma’s IMP Department plays a crucial role in the development and production of investigational medicinal products for clinical trials. Our facilities are equipped to produce a wide range of pharmaceutical products, including injections, creams, capsules, and hydrogels, all adhering to the highest quality standards.
IMPD Expertise in Primary Containers
Our IMP Department has extensive experience in handling a variety of primary containers, ensuring the highest standards of quality and safety. We specialize in:
- Vials: Ranging from 2R to 100R, suitable for various pharmaceutical applications.
- Tubes: Available in both sterile and non-sterile formats, catering to different product requirements.
- Syringes: Designed for precise dosing and ease of use.
- Capsules: Manufactured to meet stringent quality specifications.
Aseptic Processing
Our Investigation Medicinal Products Department is dedicated to the aseptic preparation and filling of investigational medicinal products. This specialization ensures that our products are manufactured in a sterile environment, minimizing the risk of contamination and ensuring the highest level of safety and efficacy for clinical trials.
Quality Assurance
Quality assurance is a cornerstone of our IMP Department. We are fully compliant with Good Manufacturing Practices (GMP) and are regularly audited by Dutch authorities to ensure adherence to the highest standards. Additionally, we comply with Annex 1 of the EudraLex, which governs the manufacture of sterile medicinal products. Our commitment to quality includes maintaining and improving quality systems, operating according to current Good Laboratory Practices (cGLP), and performing specialized analyses of cytotoxic products in dedicated isolators.
Our IMP Services and Collaboration
While our IMP Department focuses on the aseptic processing of investigational medicinal products, the Basic Pharma group offers various services to third parties, such as quality control and contract manufacturing. We regularly collaborate with partners to develop and license pharmaceutical products, making us a strong and versatile player in the pharmaceutical industry.
Services and Collaboration
At Basic Pharma, our mission is to contribute to the advancement of pharmaceutical science by providing high-quality investigational medicinal products that support clinical trials. Our dedicated team of professionals works tirelessly to ensure the quality and reliability of our products. We specialize in the aseptic preparation and filling of investigational medicinal products, which is central to our commitment to safety and efficacy.
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