• Drug development
  • Clinical trial batches

Manufacturing of clinical trial batches

We would like to support you in the successful implementation of your clinical trials and offer a comprehensive range of services.

Precision and speed for your research

We offer a broad technological and analytical spectrum for the development, manufacturing and testing of small and large molecule drugs. We are a GMP-certified company and a reliable partner for leading global pharmaceutical and biotechnology companies. We meet the highest quality standards. We can accompany complex studies and offer support in several areas of clinical trial manufacturing.

For your clinical trials, we offer support in the areas of manufacturing, packaging, release testing, QP batch release and distribution of clinical investigational medicinal products for solid, semi-solid and liquid dosage forms.

 

Our services

Clinical trial batches
  • Manufacture of liquid and semi-solid dosage forms up to 100 kg batch size
  • Manufacture of oral solid dosage forms up to 75 kg batch size
  • Manufacture of innovative dosage forms such as micro- and nanosuspensions, nanoemulsions and nasal sprays
  • Tailor-made primary, secondary and tertiary packaging
  • Labelling of primary, secondary and tertiary packaging
  • Customised labelling incl. blinding/randomisation
  • IMPD Writing
  • Development and packaging of individual patient kits
  • Release and stability testing
  • QP batch release
  • GMP storage incl. cold storage
  • Distribution under controlled conditions to clinical trial sites
  • Procurement of comparators
  • Import / export and customs clearance
Individual Labelling
  • Verified translations
  • Legal advice on local regulations
  • Single language labels / single panel labels
  • Multilingual labels/booklet labels
  • Polyethylene labels
  • Peelable labels
    On-site label printing (according to GMP regulations)
  • Generation of randomisation codes/kit lists
GMP-compliant storage
  • GMP-/GCP-compliant storage
  • Storage at room temperature (15 - 25 °C)
  • Refrigerated storage (2 - 8 °C)
  • Frozen storage (-20°C)
  • Ultra-low temperature storage (-80°C)
  • 24/7 temperature log and monitoring
  • Centralised alarm system and alternative power supply in case of emergency
  • Recovery, reconciliation, storage and destruction of IMPs

Contact us. We’re happy to help!

Katja Klein
Sales Manager

Phone: +49 7272 7767-2735
Email:

Dr. Philipp Wissel
Frankfurt Site Manager

Phone: +49 7272 7767-0
Email:

Hotline

Monday - Friday

+49 7272 7767-0