Clinical Supplies
Services
http://www.clinical-supplies.de/services.php

© 2012 Clinical Supplies

Services

Our services include

  • Production
  • Label processing
  • Batch certification
  • Packaging
  • Blinding
  • Labelling
  • Purchasing
  • International distribution of clinical trial samples

Our manual production guarantees maximum flexibility regardless of batch size.


Production under Production Authorisation in accordance with § 13 AMG

  • Production of non-sterile dosage forms, primary packaging, blinding, labelling of drugs for clinical studies (Phase I and II)

  • Secondary packaging and labelling of drugs for clinical studies (Phases I to IV)

  • Packaging and labelling of investigational new drugs for clinical trials on animals

  • Qualified persons are on hand to give clearance to investigational new drugs


Storage and Shipping

  • Temperature controlled storage
  • Inventory Management
  • Worldwide shipment of clinical trials samples
  • Cold chain service
  • Control of transport conditions
  • Utilisation of temperature loggers
  • Processing, documentation, reconciliation and storage of returned consignments

Services

  • The obtainment of drugs as reference products, concomitant or emergency medication (wholesale licence)
  • Expert consultation during the preparation of clinical trials with regard to issues relating specifically to production
  • Requirements planning and acquirement of packaging materials
  • Many years experience in the reconstitution of drugs for clinical trials (within the scope of the pharmaceutical licence)
  • Storage of reserve samples – also in accordance with FDA regulations – under predetermined conditions
  • The certified destruction of investigational new drugs