Clinical Trials Services (CTS)
Manufacturing, packaging, labelling and distribution of clinical trials supplies
NextPharma is one of the world's leading providers of clinical trial material manufacturing, packaging and distribution services.
We can provide formulation development manufacturing of IMP's, packaging design, comparator procurement, blinding, primary and secondary packaging, analytics, stability testing and microbiology testing.
Our services are supported by a Qualified Person and experts in regulatory affairs and medical product dossiers.
Services
- Assistance in the implementation of packaging design including aspects of safety, compliance and premarketing
- Requirements planning and purchase of packaging materials as well as sourcing comparative medication
- Blinding of solid dosage forms in capsules
- Bulk manufacture of active and placebo products
- Deblistering of commercial products
- Filling, packaging and labelling including randomisation
- Label design and printing
- Drawing up of randomisation lists and emergency letters
- Analytical and stability testing during studies
- Compared release of blinded forms
- Processing of controlled substances
- International distribution and shipping
We have manufactured and packaged clinical trials supplies at our Göttingen site for more than 30 years. Different dosage forms for Phase I-IV are produced with our highly experienced team in accordance with Annex 13 of the EU cGMP guidelines.
For further information please contact:
North America
Benjamin Breitfeld
Phone: +49 (2309) 93750
benjamin.breitfeld(at)nextpharma.de
Europe
Hugues Benevent
Tel: +33 6 7226 3378
hugues.benevent(at)nextpharma.fr