Experts taking care.
Contact details
Dr. Julia E. Diederichs
Head of Clinical Trial Supplies
Phone: 0049-6202-99-1505
[email protected]
Corden Pharma GmbH, Plankstadt
Clinical Supply Services
Corden Pharma GmbH
Otto-Hahn-Strasse
68723 Plankstadt
Germany
Corden Pharma’s clinical trial unit, located nearby
Heidelberg, operate in close collaboration with formulation
development, analytical services and commercial manufacturing to take advantage of the full range of capabilities,
resources and corporate infrastructure of a global acting service
provider. They are comprised of:
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R&D capabilities for solid oral dosage forms up to
commercial scale
Analytical development department
Bulk manufacturing, primary and secondary
packaging
Regulatory support for clinical trial applications
Qualified person for investigational medicinal
products
Storage, world wide distribution & logistic services
A satisfied customer:
„The past two years I‘ve worked with Corden Pharma‘s Clinical Supply Service for several
manufacturing requests related to our ongoing clinical trial. As Hermo Pharma is a small biotech
company, I‘ve been positively surprised about Corden Pharma‘s attitude to take their customers
seriously, regardless of company size or work order budget. They have been very flexible to adjust to
last minute changes or requests from the customer. (...) Scientific support has been available when
needed and Corden Pharma‘s experts have been very helpful in the project. Last but not least: the
quality of services has been excellent!“
Mrs Sigrid Booms, MSc Lic (Pharm), Director of Clinical Development, Hermo Pharma Ltd.
Experts taking care.
Clinical Manufacturing for Phase I to III Studies
• Formulation development and production of solid oral dosage forms
• Special expertise in formulating highly potent products (e.g. hormones, hormone
blockers, oncological compounds) with a clearly defined OEB level
• Fully contained plant for batch sizes up to 120 kg
• Development and production of matching placebo
• Blinding and over-encapsulation of comparators
Comparators
• Global procurement of comparator including required documentation
Label Printing and Labelling
• Label layout, art work and approval
• Booklets and multi-lingual labels
• Generation of randomisation lists and code-breaking envelopes
Packaging
• From study protocol to optimized packaging design
• Tailor-made packaging solutions for special patient groups (child resistant, senior
friendly)
• Full flexibility to manage all requirements from small scale studies to large multicenter phase III studies
• Primary packaging of oral solid dosage forms into blisters (PVC/PVDC, Aclar,
Alu/Alu)
• Filling of bottles (induction sealing and desiccant)
• Secondary packaging: Wallets, visit boxes, patient kits, center boxes
• Expiry date extention
Analytical Services
• Development and validation of analytical methods
• Stability testing according to ICH
• Release testing
• Issuance of CoA, CoC and CoR
Warehousing
• Dedicated warehouse area, plus commercial warehouse capacity
• Cold storage capacity 2-8°C and freezer storage -20°C
Distribution
• World wide distribution including
import/export
• Medication supply management
with IVRS / IWRS
• Cold chain distribution management
• Data logger system
• Reconciliation of returned drug
• Certified destruction
Clinical Supply Consulting Services
• Dedicated project manager
• IMPD and CTD writing – Quality
part / Modul 3
• Support for scientific advise and
during approval process of clinical
trial applications
• Pharmacy Service – Management
of the GMP/GCP interface
• Full QP service