Drug Products and associated Packaging Services
Analytical Development
We provide complete development of analytical methods for drug compounds, excipients and drug products to support our contracted customers. Analytical methods are developed and validated according to ICH guidelines and validated methods can either be transferred to us or developed at CordenPharma facilities to support technology transfer, scale up, process validation and ICH stability testing for bulk and packaged drug products.
Validation Support
CordenPharma provides validation support which is tailored to your needs. We assist you in producing product quality reviews (including a complete package if requested) and support the renewal of your product approvals. CordenPharma is a reliable partner from planning and execution to evaluation and validation reporting of:
- >> Products
- >> Processes
- >> Analytical Methods
- >> IT-systems
- >> Engineering Support for Equipment
Regulatory Support
Regulatory registration support for our contracted customers is organized according to the tasks and product ranges of various CordenPharma facilities, where a team of experts in the relevant technology is available on-site for registration-related questions.
As new developments arise we produce all the documentation necessary for our clients to submit the file for registration in the selected markets. On request, applications for registration can be produced and submitted via reliable service providers with whom we work.
When products change, whether it be to meet changed requirements from the registration authorities, to improve products or to ensure that medicines are safe, we take care of all the documentation, so as to successfully implement change applications known as variations.
In addition, through our registration support for contracted customers we produce the documents that are needed to retain registration in relevant markets for the medicines already produced by the facilities of CordenPharma.
Clinical Supply Services
CordenPharma’s clinical trial units operate in close collaboration with formulation development and commercial manufacturing to take advantage of the full range of capacities, resources and complete big pharma infrastructure offered by all of CordenPharma’s global facilities. They are comprised of:
- >> Clinical Manufacturing
- >> Comparator Procurement
- >> Label Printing & Labeling
- >> Label layout & approval
- >> 100% inspection of all clinical labels (four-eyes principle)
- >> Documented 100% reconciliation
- >> Generation of randomisation lists
- >> Code-breaking envelopes
- >> Multi-lingual booklet labels & wrap-around labels
- >> Packaging / Pre-production Service
- >> Interpretation of study protocols & conversion into optimized packaging design
- >> Secondary Packaging
- >> Syringes, vials & ampoules, visit boxes, patient kits, centre boxes, shipping boxes, graphic packaging design
- >> Analytical / QA-Service
- >> In-house laba
- >> Analytical method development, transfer and validation
- >> Stability tests according to ICH
- >> Release testing
- >> Issuance of CoA
- >> QP release
- >> Storage
- >> Dedicated shipping warehouse area
- >> Commercial warehouse
- >> Cold Storage Room @ 2-8°C
- >> Cold Storage Room & Freezer Storage @ -20°C
- >> Distribution
- >> Worldwide distribution
- >> IVRS / IWRS
- >> Shipment tracking with modern communication systems
- >> Cold chain distribution management, including refrigerated & frozen shipment
- >> Data logger system
- >> Return drug reconciliation & management
- >> Certified destruction
